HVAC Counter Support Associate
Job Description:
Job Duties
Assist customers/counter with ALL special orders and non-stock items
Provide product recommendations and/or price quotes
Support store and counter staff with Large line-item orders and job quotes
Direct ships - verifying shipping and freight. Bill customer and receive in PO
Work with branch manager to develop and execute sales promotions
Point of contact for ALL web orders
Overseeing pickup lockers
Any other duties as required by your supervisor
Alternative Duties
Assist with customer service and sales, including answering phones
Assist with annual physical count of full warehouse inventory and cycle counts
Assist with any special duties and assignments as needed to support the efficient functioning of the store
Assist with instore, customer training and special events
Assist with any dealer branch material and items
General Results and Responsibilities
Adheres to all company policies, procedures, standards, and business ethics codes
Maintains professional communication when interacting with customers and coworkers
Treat all customers and coworkers with a helpful and courteous attitude
Keeps communication open to maintain a healthy work environment
Report any consistent problems that are not being resolved to the supervisor
Education and Experience Required: • High School Diploma / GED required OR equivalent combination of education and experience • Clean driving record
Preferred: • Minimum 3 years of HVAC customer service or sales experience • Experience with computer or barcode-driven inventory management systems • Must be able to read blueprint to perform mechanical take-offs Job-Specific Knowledge, Skills & Abilities
Key Skills • Problem-solving skills: listening to, interpreting, and meeting the needs of others; diagnosing and rectifying problems. • Skill in following through on commitments. • Ability to manage time in a deadline-driven environment. • Strong ability to multitask and skill in prioritizing work. • Excellent communication and customer service skills. • Ability to maintain a positive and friendly demeanor in a stressful and fast-paced environment. • Ability to work efficiently and with a sense of urgency. • Ability to demonstrate considerable tact and diplomacy in dealing with others and to maintain relationships. • Ability to meet store accuracy and productivity standards.
--------------------------------------------------------------------------------------------------
Company name: Johnstone Supply – JTeam Group
Company website: https://www.johnstonesupply.com/
Company contact: Erica Wynn
Contacts email address: jteamrecruiting@jteamgroup.com
City and zip code the job is in: Raleigh - 27609
How to apply - by email or URL: https://jteamgroup.applicantpro.com/jobs/
Company phone number: 919 – 459 - 8529
Company description: Johnstone Supply is a wholesale distributor serving professional HVAC/R contractors, providing the largest selection of equipment and genuine OEM parts in the industry. Our mission is to deliver exceptional service and quality products while fostering a culture of teamwork, respect, integrity, adaptability, and service.
Joining the JTeam Group means being part of a collaborative family that values hard work and growth. Whether you are looking to kickstart your career or take the next step in your professional journey, we encourage you to explore the exciting opportunities we have available.
Job title you are hiring for: Counter Sales
Job Description:
Job Duties
Answers incoming telephone calls and greets customers who walk in the store.
Handles multiple customers and customer requests simultaneously while maintaining a friendly and professional manner.
Assists customers in making product selections by asking questions and actively listening to identify customer needs. Assists with system or product troubleshooting and answering technical questions. Identifies alternate or substitute products to meet customer needs.
Researches and sources product for customers using a variety of tools, including point-of-sale computer system, catalogs, websites, JXI, and industry and store contacts.
Enters sales orders into point-of-sale computer system for invoicing or cash payments. Processes customer returns and warranties following company guidelines.
Follows up promptly on all customer requests for information, quotes, alternative parts and delivery dates. Proactively communicates with customers about any expected delays or issues with their order.
Develops good working relationships and rapport with customers. Greets regular customers by name.
Maintains the highest standards in cleanliness and appearance of the showroom through stocking shelves, housekeeping, creating displays, etc.
Resolves customer complaints and disputes in a timely, professional manner that balances customer requests with business needs.
Follows company pricing and credit guidelines
Sales Results and Responsibilities
Prepares and issues sales quotes following company guidelines. Follows up on quotes to secure sales.
Educates customers/prospects re: the variety of products available for sale and the benefits of shopping at Johnstone Supply
Increases customer satisfaction and store profitability by proactively recommending additional items a customer might need and promotions that might interest them.
Uncovers and communicates sales lead information to outside sales staff and management.
Promotes surplus, sale, discounted and obsolete inventory to customers in order to maintain proper inventory levels. Communicates unexpected increases or decreases in product demand and inventory to purchasing or management.
Requirements
Language Proficiencies:
Proficient conversational English skills.
The ability read and write in English, as necessitated for data entry, order placement, reports, or related activities.
Education and Experience
Required:
High School Diploma or G.E.D and a minimum of two years related experience and/or training in the HVAC/R industry; OR equivalent combination of education and experience.
Preferred:
2 years experience as a Sales and Service Associate in the HVAC/R or similar industry
Conversational fluency in Spanish.
--------------------------------------------------------------------------------------------------
Company name: Johnstone Supply – JTeam Group
Company website: https://www.johnstonesupply.com/
Company contact: Erica Wynn
Contacts email address: jteamrecruiting@jteamgroup.com
City and zip code the job is in: Raleigh – 27609
How to apply - by email or URL: https://jteamgroup.applicantpro.com/jobs/
Company phone number: 919 – 459 - 8529
Company description: Johnstone Supply is a wholesale distributor serving professional HVAC/R contractors, providing the largest selection of equipment and genuine OEM parts in the industry. Our mission is to deliver exceptional service and quality products while fostering a culture of teamwork, respect, integrity, adaptability, and service.
Joining the JTeam Group means being part of a collaborative family that values hard work and growth. Whether you are looking to kickstart your career or take the next step in your professional journey, we encourage you to explore the exciting opportunities we have available.
Job title you are hiring for: Inside Sales Associate
Job Description:
Sales Results and Responsibilities
Source new sales opportunities through inbound lead follow-up and outbound calls and emails
Understand customer needs and requirements
Route qualified opportunities to the appropriate sales executives for further development and closure
Close sales and achieve monthly quotas
Research accounts, identify key players, and generate interest
Maintain and expand your database of prospects within your assigned portfolio
Assist sales executives and support key clients
Positions Johnstone products and services as a strategic advantage to customers.
Communicates Johnstone value proposition and business drivers.
Establishes and expands relationships with decision-makers within key accounts.
Develop new customers and contacts to expand the customer base.
Provides sales support to outside sales representatives whenever necessary to develop new accounts, expand existing accounts, and close business.
Maintains awareness of competitor pricing, product lines, and value propositions.
Adjusts market and sales strategies to respond to competition.
Represents Johnstone Supply at trade associations, events, and local chapters.
Education and Experience:
High School Diploma
Preferred:
Direct Sales experience in the business-to-business HVAC/R industry.
Strong focus on sales process planning and implementation.
--------------------------------------------------------------------------------------------------
Company name: Johnstone Supply – JTeam Group
Company website: https://www.johnstonesupply.com/
Company contact: Erica Wynn
Contacts email address: jteamrecruiting@jteamgroup.com
City and zip code the job is in: Raleigh - 27609
How to apply - by email or URL: https://jteamgroup.applicantpro.com/jobs/
Company phone number: 919 – 459 - 8529
Company description: Johnstone Supply is a wholesale distributor serving professional HVAC/R contractors, providing the largest selection of equipment and genuine OEM parts in the industry. Our mission is to deliver exceptional service and quality products while fostering a culture of teamwork, respect, integrity, adaptability, and service.
Joining the JTeam Group means being part of a collaborative family that values hard work and growth. Whether you are looking to kickstart your career or take the next step in your professional journey, we encourage you to explore the exciting opportunities we have available.
Job title you are hiring for: Warehouse Associate
Job Description:
Job Duties
Quickly and accurately receives, processes, and stores incoming product shipments.
Ensures shipments are inspected and damages or shortages are noted on trucking company delivery documents. Initiates freight claim procedure when necessary.
Checks incoming delivery contents against the packing list to verify accurate and full delivery.
Prepares the receiving reports and notes any shortages, damages, or overages. Promptly reports any discrepancies to supervisors.
Verifies vendor part number and Johnstone stock number for all incoming products. Determines proper bin number and/or location of incoming products. Stores incoming products in proper location according to bin number or product sequence.
Select products from inventory to fill customer orders.
Prepares, packs, and scans (as appropriate), and stages products for inter-store transfer and customer pick-up and delivery in accordance with established standards (e.g. hazardous materials). Ensures that packaging is sufficient to avoid damage.
Processes documentation necessary to ship inter-store transfers and customer orders, including bills of lading, packing lists, small parcel manifests and other necessary documents.
Loads delivery vehicles and assists customers with will call pickups.
Processes customer returns. Ensures returns are in sellable condition per company policy.
Verifies that warranty paperwork has been properly and neatly filled out. Initiates warranty return process, and stages product in warranty area.
Performs periodic cycle counting on assigned items in order to keep accurate records of inventory. Verifies actual counts of stock against computerized records. Investigates and reports discrepancies.
Ensures safety by maintaining cleanliness of warehouse. Ensures that aisles are free of potential hazards. Reports unsafe conditions to management.
Operates hand trucks, pallet jacks, forklifts, order pickers, and other equipment safely and in accordance with organizational procedures. Monitors equipment and promptly reports any safety or maintenance concerns to supervisors.
Always wear protective equipment according to company policies and procedures. Accesses Material Safety Data Sheets (MSDS) as needed and when appropriate.
Maintains required hazardous materials, forklift, and other internal and external certifications.
Education and Experience Requirements:
High School Diploma / GED required OR equivalent combination of education and experience
Valid Driver's License
Clean driving record
Job-Specific Knowledge, Skills & Abilities:
Basic computer skills, including knowledge and skill in the use of inventory management systems and office software (e.g. Email programs, Internet browsers)
Basic math skills sufficient to manage inventory, including addition, subtraction, multiplication, and division.
Ability to use computer systems and manual procedures for organizing and identifying products and communicating with coworkers.
Adequate physical strength and stamina to repeatedly lift, carry, move, and set down up to 75 pounds.
Skill in the operation of heavy equipment, including delivery vehicles, forklifts, pallet jacks, and order pickers.
Strict attention to detail
Company name: Johnstone Supply – JTeam Group
Company website: https://www.johnstonesupply.com/
Company contact: Erica Wynn
Contacts email address: jteamrecruiting@jteamgroup.com
City and zip code the job is in: Garner – 27603
How to apply - by email or URL: https://jteamgroup.applicantpro.com/jobs/
Company phone number: 919 – 459 - 8529
Company description: Johnstone Supply is a wholesale distributor serving professional HVAC/R contractors, providing the largest selection of equipment and genuine OEM parts in the industry. Our mission is to deliver exceptional service and quality products while fostering a culture of teamwork, respect, integrity, adaptability, and service.
Joining the JTeam Group means being part of a collaborative family that values hard work and growth. Whether you are looking to kickstart your career or take the next step in your professional journey, we encourage you to explore the exciting opportunities we have available.
Job title you are hiring for: Accountant I
Job Description:
This is an entry level position that will work extensively with the treasury management function for a multi-divisional company with approximately $60 million in sales. As part of the treasury management function, the position requires a thorough knowledge and understanding of bank reconciliations. The candidate must be able to multi-task and establish priorities with little supervision. This position also reconciles and analyzes certain accounts at month-end for use in issuing financial statements. This position may also be responsible for portions of the daily accounts payable function to include data entry.
Job Duties:
70% Treasury Functions and Accounts Payable to include data entry
20% Analysis of general ledger accounts for month end closing process
5% Credit collection and approval process
5% Other duties as directed
Professional Characteristics:
Priority will be given to a person with a 4-year or 2-year accounting degree or commensurate experience.
Personal Characteristics:
An individual with the highest degree of personal integrity
Ability to multi-task and enjoy daily challenges
Ability to work in a small company environment
Possess a thorough knowledgeable and be proficient with Microsoft Word and Excel
Willingness to learn industry specific software
Detail oriented in job performance
Possess a sound understanding of the accounting cycle
Jan 13, 2025
Full time
HVAC Counter Support Associate
Job Description:
Job Duties
Assist customers/counter with ALL special orders and non-stock items
Provide product recommendations and/or price quotes
Support store and counter staff with Large line-item orders and job quotes
Direct ships - verifying shipping and freight. Bill customer and receive in PO
Work with branch manager to develop and execute sales promotions
Point of contact for ALL web orders
Overseeing pickup lockers
Any other duties as required by your supervisor
Alternative Duties
Assist with customer service and sales, including answering phones
Assist with annual physical count of full warehouse inventory and cycle counts
Assist with any special duties and assignments as needed to support the efficient functioning of the store
Assist with instore, customer training and special events
Assist with any dealer branch material and items
General Results and Responsibilities
Adheres to all company policies, procedures, standards, and business ethics codes
Maintains professional communication when interacting with customers and coworkers
Treat all customers and coworkers with a helpful and courteous attitude
Keeps communication open to maintain a healthy work environment
Report any consistent problems that are not being resolved to the supervisor
Education and Experience Required: • High School Diploma / GED required OR equivalent combination of education and experience • Clean driving record
Preferred: • Minimum 3 years of HVAC customer service or sales experience • Experience with computer or barcode-driven inventory management systems • Must be able to read blueprint to perform mechanical take-offs Job-Specific Knowledge, Skills & Abilities
Key Skills • Problem-solving skills: listening to, interpreting, and meeting the needs of others; diagnosing and rectifying problems. • Skill in following through on commitments. • Ability to manage time in a deadline-driven environment. • Strong ability to multitask and skill in prioritizing work. • Excellent communication and customer service skills. • Ability to maintain a positive and friendly demeanor in a stressful and fast-paced environment. • Ability to work efficiently and with a sense of urgency. • Ability to demonstrate considerable tact and diplomacy in dealing with others and to maintain relationships. • Ability to meet store accuracy and productivity standards.
--------------------------------------------------------------------------------------------------
Company name: Johnstone Supply – JTeam Group
Company website: https://www.johnstonesupply.com/
Company contact: Erica Wynn
Contacts email address: jteamrecruiting@jteamgroup.com
City and zip code the job is in: Raleigh - 27609
How to apply - by email or URL: https://jteamgroup.applicantpro.com/jobs/
Company phone number: 919 – 459 - 8529
Company description: Johnstone Supply is a wholesale distributor serving professional HVAC/R contractors, providing the largest selection of equipment and genuine OEM parts in the industry. Our mission is to deliver exceptional service and quality products while fostering a culture of teamwork, respect, integrity, adaptability, and service.
Joining the JTeam Group means being part of a collaborative family that values hard work and growth. Whether you are looking to kickstart your career or take the next step in your professional journey, we encourage you to explore the exciting opportunities we have available.
Job title you are hiring for: Counter Sales
Job Description:
Job Duties
Answers incoming telephone calls and greets customers who walk in the store.
Handles multiple customers and customer requests simultaneously while maintaining a friendly and professional manner.
Assists customers in making product selections by asking questions and actively listening to identify customer needs. Assists with system or product troubleshooting and answering technical questions. Identifies alternate or substitute products to meet customer needs.
Researches and sources product for customers using a variety of tools, including point-of-sale computer system, catalogs, websites, JXI, and industry and store contacts.
Enters sales orders into point-of-sale computer system for invoicing or cash payments. Processes customer returns and warranties following company guidelines.
Follows up promptly on all customer requests for information, quotes, alternative parts and delivery dates. Proactively communicates with customers about any expected delays or issues with their order.
Develops good working relationships and rapport with customers. Greets regular customers by name.
Maintains the highest standards in cleanliness and appearance of the showroom through stocking shelves, housekeeping, creating displays, etc.
Resolves customer complaints and disputes in a timely, professional manner that balances customer requests with business needs.
Follows company pricing and credit guidelines
Sales Results and Responsibilities
Prepares and issues sales quotes following company guidelines. Follows up on quotes to secure sales.
Educates customers/prospects re: the variety of products available for sale and the benefits of shopping at Johnstone Supply
Increases customer satisfaction and store profitability by proactively recommending additional items a customer might need and promotions that might interest them.
Uncovers and communicates sales lead information to outside sales staff and management.
Promotes surplus, sale, discounted and obsolete inventory to customers in order to maintain proper inventory levels. Communicates unexpected increases or decreases in product demand and inventory to purchasing or management.
Requirements
Language Proficiencies:
Proficient conversational English skills.
The ability read and write in English, as necessitated for data entry, order placement, reports, or related activities.
Education and Experience
Required:
High School Diploma or G.E.D and a minimum of two years related experience and/or training in the HVAC/R industry; OR equivalent combination of education and experience.
Preferred:
2 years experience as a Sales and Service Associate in the HVAC/R or similar industry
Conversational fluency in Spanish.
--------------------------------------------------------------------------------------------------
Company name: Johnstone Supply – JTeam Group
Company website: https://www.johnstonesupply.com/
Company contact: Erica Wynn
Contacts email address: jteamrecruiting@jteamgroup.com
City and zip code the job is in: Raleigh – 27609
How to apply - by email or URL: https://jteamgroup.applicantpro.com/jobs/
Company phone number: 919 – 459 - 8529
Company description: Johnstone Supply is a wholesale distributor serving professional HVAC/R contractors, providing the largest selection of equipment and genuine OEM parts in the industry. Our mission is to deliver exceptional service and quality products while fostering a culture of teamwork, respect, integrity, adaptability, and service.
Joining the JTeam Group means being part of a collaborative family that values hard work and growth. Whether you are looking to kickstart your career or take the next step in your professional journey, we encourage you to explore the exciting opportunities we have available.
Job title you are hiring for: Inside Sales Associate
Job Description:
Sales Results and Responsibilities
Source new sales opportunities through inbound lead follow-up and outbound calls and emails
Understand customer needs and requirements
Route qualified opportunities to the appropriate sales executives for further development and closure
Close sales and achieve monthly quotas
Research accounts, identify key players, and generate interest
Maintain and expand your database of prospects within your assigned portfolio
Assist sales executives and support key clients
Positions Johnstone products and services as a strategic advantage to customers.
Communicates Johnstone value proposition and business drivers.
Establishes and expands relationships with decision-makers within key accounts.
Develop new customers and contacts to expand the customer base.
Provides sales support to outside sales representatives whenever necessary to develop new accounts, expand existing accounts, and close business.
Maintains awareness of competitor pricing, product lines, and value propositions.
Adjusts market and sales strategies to respond to competition.
Represents Johnstone Supply at trade associations, events, and local chapters.
Education and Experience:
High School Diploma
Preferred:
Direct Sales experience in the business-to-business HVAC/R industry.
Strong focus on sales process planning and implementation.
--------------------------------------------------------------------------------------------------
Company name: Johnstone Supply – JTeam Group
Company website: https://www.johnstonesupply.com/
Company contact: Erica Wynn
Contacts email address: jteamrecruiting@jteamgroup.com
City and zip code the job is in: Raleigh - 27609
How to apply - by email or URL: https://jteamgroup.applicantpro.com/jobs/
Company phone number: 919 – 459 - 8529
Company description: Johnstone Supply is a wholesale distributor serving professional HVAC/R contractors, providing the largest selection of equipment and genuine OEM parts in the industry. Our mission is to deliver exceptional service and quality products while fostering a culture of teamwork, respect, integrity, adaptability, and service.
Joining the JTeam Group means being part of a collaborative family that values hard work and growth. Whether you are looking to kickstart your career or take the next step in your professional journey, we encourage you to explore the exciting opportunities we have available.
Job title you are hiring for: Warehouse Associate
Job Description:
Job Duties
Quickly and accurately receives, processes, and stores incoming product shipments.
Ensures shipments are inspected and damages or shortages are noted on trucking company delivery documents. Initiates freight claim procedure when necessary.
Checks incoming delivery contents against the packing list to verify accurate and full delivery.
Prepares the receiving reports and notes any shortages, damages, or overages. Promptly reports any discrepancies to supervisors.
Verifies vendor part number and Johnstone stock number for all incoming products. Determines proper bin number and/or location of incoming products. Stores incoming products in proper location according to bin number or product sequence.
Select products from inventory to fill customer orders.
Prepares, packs, and scans (as appropriate), and stages products for inter-store transfer and customer pick-up and delivery in accordance with established standards (e.g. hazardous materials). Ensures that packaging is sufficient to avoid damage.
Processes documentation necessary to ship inter-store transfers and customer orders, including bills of lading, packing lists, small parcel manifests and other necessary documents.
Loads delivery vehicles and assists customers with will call pickups.
Processes customer returns. Ensures returns are in sellable condition per company policy.
Verifies that warranty paperwork has been properly and neatly filled out. Initiates warranty return process, and stages product in warranty area.
Performs periodic cycle counting on assigned items in order to keep accurate records of inventory. Verifies actual counts of stock against computerized records. Investigates and reports discrepancies.
Ensures safety by maintaining cleanliness of warehouse. Ensures that aisles are free of potential hazards. Reports unsafe conditions to management.
Operates hand trucks, pallet jacks, forklifts, order pickers, and other equipment safely and in accordance with organizational procedures. Monitors equipment and promptly reports any safety or maintenance concerns to supervisors.
Always wear protective equipment according to company policies and procedures. Accesses Material Safety Data Sheets (MSDS) as needed and when appropriate.
Maintains required hazardous materials, forklift, and other internal and external certifications.
Education and Experience Requirements:
High School Diploma / GED required OR equivalent combination of education and experience
Valid Driver's License
Clean driving record
Job-Specific Knowledge, Skills & Abilities:
Basic computer skills, including knowledge and skill in the use of inventory management systems and office software (e.g. Email programs, Internet browsers)
Basic math skills sufficient to manage inventory, including addition, subtraction, multiplication, and division.
Ability to use computer systems and manual procedures for organizing and identifying products and communicating with coworkers.
Adequate physical strength and stamina to repeatedly lift, carry, move, and set down up to 75 pounds.
Skill in the operation of heavy equipment, including delivery vehicles, forklifts, pallet jacks, and order pickers.
Strict attention to detail
Company name: Johnstone Supply – JTeam Group
Company website: https://www.johnstonesupply.com/
Company contact: Erica Wynn
Contacts email address: jteamrecruiting@jteamgroup.com
City and zip code the job is in: Garner – 27603
How to apply - by email or URL: https://jteamgroup.applicantpro.com/jobs/
Company phone number: 919 – 459 - 8529
Company description: Johnstone Supply is a wholesale distributor serving professional HVAC/R contractors, providing the largest selection of equipment and genuine OEM parts in the industry. Our mission is to deliver exceptional service and quality products while fostering a culture of teamwork, respect, integrity, adaptability, and service.
Joining the JTeam Group means being part of a collaborative family that values hard work and growth. Whether you are looking to kickstart your career or take the next step in your professional journey, we encourage you to explore the exciting opportunities we have available.
Job title you are hiring for: Accountant I
Job Description:
This is an entry level position that will work extensively with the treasury management function for a multi-divisional company with approximately $60 million in sales. As part of the treasury management function, the position requires a thorough knowledge and understanding of bank reconciliations. The candidate must be able to multi-task and establish priorities with little supervision. This position also reconciles and analyzes certain accounts at month-end for use in issuing financial statements. This position may also be responsible for portions of the daily accounts payable function to include data entry.
Job Duties:
70% Treasury Functions and Accounts Payable to include data entry
20% Analysis of general ledger accounts for month end closing process
5% Credit collection and approval process
5% Other duties as directed
Professional Characteristics:
Priority will be given to a person with a 4-year or 2-year accounting degree or commensurate experience.
Personal Characteristics:
An individual with the highest degree of personal integrity
Ability to multi-task and enjoy daily challenges
Ability to work in a small company environment
Possess a thorough knowledgeable and be proficient with Microsoft Word and Excel
Willingness to learn industry specific software
Detail oriented in job performance
Possess a sound understanding of the accounting cycle
The Senior MSAT/Process Engineer will support the GMP manufacturing of Humacyte’s unique HAV and related products with limited supervision and guidance. This role will collaborate effectively with personnel in Manufacturing, Engineering, Process Development, Quality Assurance, and Quality Control utilizing strong communication, technical expertise and influencing skills to maintain and improve manufacturing operations.
Remote Work Designation : Not Remote
Major Accountabilities:
Serves as a process expert in HAV production systems; able to fully understand the manufacturing process
Primary responsible person to ensure bioprocessing equipment is ready for use when required
Identifies technical issues on bioprocessing equipment and initiates activities to resolve the issue quickly. Identifies and implements procedures and activities to prevent the same issue from occurring.
Lead efforts in troubleshooting out-of-trend manufacturing processes, providing the intellectual, scientific and engineering leadership to identify and implement corrective actions
Provides guidance and is accountable for determining the root causes of equipment related deviations in a timely and conclusive manner.
Ensures deep understanding of standards of practice, process science and departmental policies through participation in training and development opportunities
Provides comprehensive training and guidance to operations staff
Partner with Process Development to ensure successful process transfer
Assist in equipment selection and design, qualification, and start up activities. Work with Bioprocessing to ensure robust procedures are utilized for operation of equipment
Develop and execute test protocols, vendor site visits, FAT/SAT, etc.
Work with the Validation team to develop and execute validation strategies
Identify continuous improvement opportunities in terms of cost savings, process robustness, and manufacturing efficiency gains
Special Competencies:
Possess a demonstrated proficiency working in a Process Engineering role with a clear understanding of GMP manufacturing
Possess a demonstrated technical foundation of cell- and tissue- based products
Strong Scientific and Engineering technical experience performing and supporting cell culture based bioprocessing activities, using adherent mammalian cells preferred
Experience supporting and troubleshooting single use bioprocessing technologies as well as fixed stainless steel bioprocessing equipment
Experience leading projects related to bioprocessing deviations, change control, process optimization, technical troubleshooting, and bioprocessing process changes
Works and leads well in a team environment
Strong experience working cross functionally within a BioPharma Bioprocessing organization
General Competencies:
Able to communicate effectively in English, both verbally and in writing
Possess a positive roll-up-the-sleeves attitude and optimistic outlook
Represents the organization in a positive and professional manner
Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
Excellent organizational and time management skills with ability to set own priorities in a timely manner
High degree of flexibility and adaptability
Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
Must be able to work as needed to meet tight deadlines and at peak periods
Self-motivated and organized critical thinker with solid interpersonal and business communication skills
Demonstrated ability to work in a cross functional team
Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
Always observe safety precautions and regulations in all areas where duties are performed
Responsible for reporting all safety hazards and potential unsafe working conditions
Reports to work on time and as scheduled
Qualifications:
BS degree in relevant discipline, required.
Master’s degree or above in related discipline, preferred.
Background in chemical engineering, biochemical engineering, biotechnology, bioprocess, cell technology, biomedical engineering, cell therapy, tissue engineering, regenerative medicine, or process development required
10 years of relevant pharma or biotech industry experience, minimum 5 years GMP experience required
Apr 24, 2024
Full time
The Senior MSAT/Process Engineer will support the GMP manufacturing of Humacyte’s unique HAV and related products with limited supervision and guidance. This role will collaborate effectively with personnel in Manufacturing, Engineering, Process Development, Quality Assurance, and Quality Control utilizing strong communication, technical expertise and influencing skills to maintain and improve manufacturing operations.
Remote Work Designation : Not Remote
Major Accountabilities:
Serves as a process expert in HAV production systems; able to fully understand the manufacturing process
Primary responsible person to ensure bioprocessing equipment is ready for use when required
Identifies technical issues on bioprocessing equipment and initiates activities to resolve the issue quickly. Identifies and implements procedures and activities to prevent the same issue from occurring.
Lead efforts in troubleshooting out-of-trend manufacturing processes, providing the intellectual, scientific and engineering leadership to identify and implement corrective actions
Provides guidance and is accountable for determining the root causes of equipment related deviations in a timely and conclusive manner.
Ensures deep understanding of standards of practice, process science and departmental policies through participation in training and development opportunities
Provides comprehensive training and guidance to operations staff
Partner with Process Development to ensure successful process transfer
Assist in equipment selection and design, qualification, and start up activities. Work with Bioprocessing to ensure robust procedures are utilized for operation of equipment
Develop and execute test protocols, vendor site visits, FAT/SAT, etc.
Work with the Validation team to develop and execute validation strategies
Identify continuous improvement opportunities in terms of cost savings, process robustness, and manufacturing efficiency gains
Special Competencies:
Possess a demonstrated proficiency working in a Process Engineering role with a clear understanding of GMP manufacturing
Possess a demonstrated technical foundation of cell- and tissue- based products
Strong Scientific and Engineering technical experience performing and supporting cell culture based bioprocessing activities, using adherent mammalian cells preferred
Experience supporting and troubleshooting single use bioprocessing technologies as well as fixed stainless steel bioprocessing equipment
Experience leading projects related to bioprocessing deviations, change control, process optimization, technical troubleshooting, and bioprocessing process changes
Works and leads well in a team environment
Strong experience working cross functionally within a BioPharma Bioprocessing organization
General Competencies:
Able to communicate effectively in English, both verbally and in writing
Possess a positive roll-up-the-sleeves attitude and optimistic outlook
Represents the organization in a positive and professional manner
Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
Excellent organizational and time management skills with ability to set own priorities in a timely manner
High degree of flexibility and adaptability
Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
Must be able to work as needed to meet tight deadlines and at peak periods
Self-motivated and organized critical thinker with solid interpersonal and business communication skills
Demonstrated ability to work in a cross functional team
Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
Always observe safety precautions and regulations in all areas where duties are performed
Responsible for reporting all safety hazards and potential unsafe working conditions
Reports to work on time and as scheduled
Qualifications:
BS degree in relevant discipline, required.
Master’s degree or above in related discipline, preferred.
Background in chemical engineering, biochemical engineering, biotechnology, bioprocess, cell technology, biomedical engineering, cell therapy, tissue engineering, regenerative medicine, or process development required
10 years of relevant pharma or biotech industry experience, minimum 5 years GMP experience required
The Manufacturing Technical Operations III provides basic to advanced technical support for the manufacturing process and is a key liaison between the manufacturing and Humacyte MSAT teams.
Remote Work Designation : Onsite/Not Remote
Major Accountabilities:
Performs moderate to advanced scope processes and serves as a hands-on resource in Manufacturing Humacyte’s regenerative vessels by:
Provides daily technical floor support for clinical or commercial manufacturing operations.
Utilizes advanced process knowledge to identify and provide primary response to manufacturing events and ensures troubleshooting support for challenges identified.
Interfaces and acts as liaison between Manufacturing Operations and Manufacturing Science and Technology teams.
Performs deviation management support, including initiation, impact assessment, and investigation ownership as needed.
Performs daily activities required of vessel production as needed to support peaks in production volume.
Leads change control or small to mid-scale projects.
Provides compliance review and/or approval for relevant GMP documents, deviations, CAPAs, change controls, SOPs as needed.
Recognizes and solves typical and atypical problems that occur in own work area without supervisory approval.
Supports projects of moderate to large scope (e.g. operational excellence, safety).
Supports the collection and tracking of area metrics and process control data.
Ensures process steps are executed according to defined SOPs and BPRs and partners with team members to ensure understanding and accuracy.
Ensures thorough and proper documentation of activities in accordance with cGMPs.
Adheres to the proper handling of chemically hazardous goods.
Interfaces with process automation and electronic business systems.
Supports, and may lead, the revisions of SOPs and BPRs.
Supports, and may lead, qualifications and validation activities, as assigned.
In collaboration with Bioprocessing leadership, recognizes, troubleshoots, and initiates deviations for process issues of moderate scope.
Supports team effort in the effective and timely completion of root cause investigations and CAPA implementation.
Provides continuous training of other team members on standard roles as needed.
Ensures Humacyte or other required trainings/certifications are up to date.
Other duties, as assigned.
Special Skills:
Works within clearly defined standard operating procedures (SOPs) and/or scientific methods.
Uses advanced knowledge of cGMP manufacturing, Humacyte’s manufacturing process, analytical skills, and application of scientific methods or operational processes to perform a variety of activities.
Provides recommended solutions and steps for resolution to problems of moderate complexity to leadership.
Identifies areas or situations with greater complexity and partners with the Humacyte MSAT team to ensure appropriate resolution.
Possesses deep and strong technical skills and the ability to translate those technical skills into problem solving and solutions.
Has ability to differentiate between important and less important tasks within own work and act accordingly.
Strong, proactive communicator that is able to interface effectively across multiple departments with support as needed.
Qualifications:
Requires a Bachelor’s Degree, or equivalent on the job experience. Master’s degree or above preferred.
5+ years of previous experience in pharmaceutical, biotechnology, and/or sterile production environments, required.
Strong knowledge of cGMP requirements, required.
Experience executing SOPs and demonstrated thorough and strong documenting work, required.
Moderate to advanced mechanical aptitude or knowledge of electrical / mechanical equipment, preferred.
Previous cell culture experience, highly preferred.
Will spend time in a clean room environment for manufacturing operations and will be required to meet applicable gowning and personal protective equipment guidelines.
General Competencies:
Able to communicate effectively in English, both verbally and in writing
Excellent communication and interpersonal skills
Possess a positive roll-up-the-sleeves attitude and optimistic outlook
Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
Excellent organizational and time management skills with ability to set own priorities in a timely manner
High degree of flexibility and adaptability
Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
Must be able to work as needed to meet tight deadlines and at peak periods
Self-motivated and organized critical thinker with solid interpersonal and business communication skills
Demonstrated ability to work in a cross-functional team environment
Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
Ensures Humacyte or other required trainings/certifications are up to date
Represents the organization in a positive and professional manner
Reports to work on time and as scheduled
Apr 24, 2024
Full time
The Manufacturing Technical Operations III provides basic to advanced technical support for the manufacturing process and is a key liaison between the manufacturing and Humacyte MSAT teams.
Remote Work Designation : Onsite/Not Remote
Major Accountabilities:
Performs moderate to advanced scope processes and serves as a hands-on resource in Manufacturing Humacyte’s regenerative vessels by:
Provides daily technical floor support for clinical or commercial manufacturing operations.
Utilizes advanced process knowledge to identify and provide primary response to manufacturing events and ensures troubleshooting support for challenges identified.
Interfaces and acts as liaison between Manufacturing Operations and Manufacturing Science and Technology teams.
Performs deviation management support, including initiation, impact assessment, and investigation ownership as needed.
Performs daily activities required of vessel production as needed to support peaks in production volume.
Leads change control or small to mid-scale projects.
Provides compliance review and/or approval for relevant GMP documents, deviations, CAPAs, change controls, SOPs as needed.
Recognizes and solves typical and atypical problems that occur in own work area without supervisory approval.
Supports projects of moderate to large scope (e.g. operational excellence, safety).
Supports the collection and tracking of area metrics and process control data.
Ensures process steps are executed according to defined SOPs and BPRs and partners with team members to ensure understanding and accuracy.
Ensures thorough and proper documentation of activities in accordance with cGMPs.
Adheres to the proper handling of chemically hazardous goods.
Interfaces with process automation and electronic business systems.
Supports, and may lead, the revisions of SOPs and BPRs.
Supports, and may lead, qualifications and validation activities, as assigned.
In collaboration with Bioprocessing leadership, recognizes, troubleshoots, and initiates deviations for process issues of moderate scope.
Supports team effort in the effective and timely completion of root cause investigations and CAPA implementation.
Provides continuous training of other team members on standard roles as needed.
Ensures Humacyte or other required trainings/certifications are up to date.
Other duties, as assigned.
Special Skills:
Works within clearly defined standard operating procedures (SOPs) and/or scientific methods.
Uses advanced knowledge of cGMP manufacturing, Humacyte’s manufacturing process, analytical skills, and application of scientific methods or operational processes to perform a variety of activities.
Provides recommended solutions and steps for resolution to problems of moderate complexity to leadership.
Identifies areas or situations with greater complexity and partners with the Humacyte MSAT team to ensure appropriate resolution.
Possesses deep and strong technical skills and the ability to translate those technical skills into problem solving and solutions.
Has ability to differentiate between important and less important tasks within own work and act accordingly.
Strong, proactive communicator that is able to interface effectively across multiple departments with support as needed.
Qualifications:
Requires a Bachelor’s Degree, or equivalent on the job experience. Master’s degree or above preferred.
5+ years of previous experience in pharmaceutical, biotechnology, and/or sterile production environments, required.
Strong knowledge of cGMP requirements, required.
Experience executing SOPs and demonstrated thorough and strong documenting work, required.
Moderate to advanced mechanical aptitude or knowledge of electrical / mechanical equipment, preferred.
Previous cell culture experience, highly preferred.
Will spend time in a clean room environment for manufacturing operations and will be required to meet applicable gowning and personal protective equipment guidelines.
General Competencies:
Able to communicate effectively in English, both verbally and in writing
Excellent communication and interpersonal skills
Possess a positive roll-up-the-sleeves attitude and optimistic outlook
Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
Excellent organizational and time management skills with ability to set own priorities in a timely manner
High degree of flexibility and adaptability
Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
Must be able to work as needed to meet tight deadlines and at peak periods
Self-motivated and organized critical thinker with solid interpersonal and business communication skills
Demonstrated ability to work in a cross-functional team environment
Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
Ensures Humacyte or other required trainings/certifications are up to date
Represents the organization in a positive and professional manner
Reports to work on time and as scheduled
The MSAT Engineer - Analytics will support the development and execution of process analytics, process support, and control strategy activities with limited supervision and guidance. This role will be ~50% process analytics and 50% process engineering support. This role will collaborate effectively with personnel in Manufacturing, Engineering, Process Development, Quality Assurance, and Quality Control utilizing strong communication, and technical expertise to maintain and improve manufacturing operations.
Remote Work Designation : Not Remote
Major Accountabilities:
Provides advanced level support for execution and development of the manufacturing control strategy and Process Analytics program
Acquires, analyses, and reports data trends using graphical and statistical methods and utilizes expertise to make recommendations to next level management based on data analysis
Develops systems and processes for the acquisition and analysis of data trends from process, equipment, and raw materials.
Applies statistical process control techniques to independently develop and implement (following appropriate change control) process specifications, parameters, operating ranges, and action limits.
Supports the execution of commercial manufacturing campaigns
Provides guidance to others on advanced and/or moderately complex theory and concepts behind the process including an understanding of the impact of any process changes or improvements, as well as the impact of any process deviations or drift
Proactively identifies technical issues on bioprocessing equipment and recommends activities to resolve the issue. Implements procedures and activities to prevent the same issue from occurring.
Authors standard operating procedures, reports, and protocols and solicit next level manager approval for final documents
Special Competencies:
Advanced knowledge of statistical process control methods and data interpretation
Knowledge of multivariate modeling techniques
Familiarity with data engineering concept for collection, storage, and validation of data
Demonstrated technical foundation of cell- and tissue- based products and a strong familiarity with GMP manufacturing
Able to independently troubleshoot advanced or moderately complex bioprocess activities and perform typical and atypical bioprocess optimization studies
Possesses advanced knowledge of the cell biological aspects of the process, as well as the engineering and mass-transfer aspects of the process
Possesses understanding and demonstrated knowledge of equipment and procedures and identifies potential problem before they occur
General Competencies:
Able to communicate effectively in English, both verbally and in writing
Possess a positive roll-up-the-sleeves attitude and optimistic outlook
Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
Excellent organizational and time management skills with ability to set own priorities in a timely manner
High degree of flexibility and adaptability
Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
Must be able to work as needed to meet tight deadlines and at peak periods
Self-motivated and organized critical thinker with solid interpersonal and business communication skills
Demonstrated ability to work in a cross functional team
Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
Always observe safety precautions and regulations in all areas where duties are performed
Responsible for reporting all safety hazards and potential unsafe working conditions
Ensures Humacyte or other required trainings/certifications are up to date
Represents the organization in a positive and professional manner
Reports to work on time and as scheduled
Qualifications:
BS in Engineering or other relevant discipline required.
MS in related discipline preferred.
Background in chemical engineering, biochemical engineering, biotechnology, bioprocess, cell therapy, tissue engineering, regenerative medicine, or process development required.
Minimum of 2 years of commercial manufacturing or Phase 3 CDMO or 6 years Phase 1-3 clinical manufacturing experience required.
Demonstrated experience with the Process Validation Lifecycle and Statistical Process Control methods
Experience with application of analytical systems and computational methods to biological systems in a GMP environment
Demonstrated experience leading basic troubleshooting and participating in complex troubleshooting/
Possess a demonstrated technical foundation of cell- and tissue- based products.
Experience with bioprocessing deviations, change control, process optimization, and technical troubleshooting.
Works well in a team environment.
Strong experience working cross functionally within a BioPharma Bioprocessing organization.
Apr 24, 2024
Full time
The MSAT Engineer - Analytics will support the development and execution of process analytics, process support, and control strategy activities with limited supervision and guidance. This role will be ~50% process analytics and 50% process engineering support. This role will collaborate effectively with personnel in Manufacturing, Engineering, Process Development, Quality Assurance, and Quality Control utilizing strong communication, and technical expertise to maintain and improve manufacturing operations.
Remote Work Designation : Not Remote
Major Accountabilities:
Provides advanced level support for execution and development of the manufacturing control strategy and Process Analytics program
Acquires, analyses, and reports data trends using graphical and statistical methods and utilizes expertise to make recommendations to next level management based on data analysis
Develops systems and processes for the acquisition and analysis of data trends from process, equipment, and raw materials.
Applies statistical process control techniques to independently develop and implement (following appropriate change control) process specifications, parameters, operating ranges, and action limits.
Supports the execution of commercial manufacturing campaigns
Provides guidance to others on advanced and/or moderately complex theory and concepts behind the process including an understanding of the impact of any process changes or improvements, as well as the impact of any process deviations or drift
Proactively identifies technical issues on bioprocessing equipment and recommends activities to resolve the issue. Implements procedures and activities to prevent the same issue from occurring.
Authors standard operating procedures, reports, and protocols and solicit next level manager approval for final documents
Special Competencies:
Advanced knowledge of statistical process control methods and data interpretation
Knowledge of multivariate modeling techniques
Familiarity with data engineering concept for collection, storage, and validation of data
Demonstrated technical foundation of cell- and tissue- based products and a strong familiarity with GMP manufacturing
Able to independently troubleshoot advanced or moderately complex bioprocess activities and perform typical and atypical bioprocess optimization studies
Possesses advanced knowledge of the cell biological aspects of the process, as well as the engineering and mass-transfer aspects of the process
Possesses understanding and demonstrated knowledge of equipment and procedures and identifies potential problem before they occur
General Competencies:
Able to communicate effectively in English, both verbally and in writing
Possess a positive roll-up-the-sleeves attitude and optimistic outlook
Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
Excellent organizational and time management skills with ability to set own priorities in a timely manner
High degree of flexibility and adaptability
Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
Must be able to work as needed to meet tight deadlines and at peak periods
Self-motivated and organized critical thinker with solid interpersonal and business communication skills
Demonstrated ability to work in a cross functional team
Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
Always observe safety precautions and regulations in all areas where duties are performed
Responsible for reporting all safety hazards and potential unsafe working conditions
Ensures Humacyte or other required trainings/certifications are up to date
Represents the organization in a positive and professional manner
Reports to work on time and as scheduled
Qualifications:
BS in Engineering or other relevant discipline required.
MS in related discipline preferred.
Background in chemical engineering, biochemical engineering, biotechnology, bioprocess, cell therapy, tissue engineering, regenerative medicine, or process development required.
Minimum of 2 years of commercial manufacturing or Phase 3 CDMO or 6 years Phase 1-3 clinical manufacturing experience required.
Demonstrated experience with the Process Validation Lifecycle and Statistical Process Control methods
Experience with application of analytical systems and computational methods to biological systems in a GMP environment
Demonstrated experience leading basic troubleshooting and participating in complex troubleshooting/
Possess a demonstrated technical foundation of cell- and tissue- based products.
Experience with bioprocessing deviations, change control, process optimization, and technical troubleshooting.
Works well in a team environment.
Strong experience working cross functionally within a BioPharma Bioprocessing organization.
Humacyte, Inc. is bringing to market a once in a generation scientific technology platform, bioengineering readily available and universally implantable product opportunities focused on improving lives of patients and transforming the practice of medicine. Located in Durham, NC, the company develops and manufactures acellular tissues for the treatment of diseases and conditions across a wide range of therapeutic areas. The company’s innovative technology supports tissue repair, reconstruction, and replacement while overcoming limitations in existing standards of care. Initially developing a portfolio of human acellular vessels (HAVs), to target multiple vascular markets including trauma, arteriovenous access for hemodialysis, peripheral arterial disease, and coronary artery bypass grafting. Humacyte is also focused on the development of future markets such as pediatric heart surgery, delivery of cellular therapies, and multiple other novel cell and tissue systems.
We are looking for additional colleagues to continue to build our expanding team. Candidates will be expected to work both independently and collaboratively as part of the Humacyte organization. Applicants must be highly self-motivated, with solid communication skills, and demonstrates the ability to work in a team environment and lead other professionals and peers.
Position Background:
We are searching for a Manager, Regulatory Affairs Labeling and Operations with a solutions oriented, roll-up-your-sleeves, attitude to join the Regulatory Affairs team, collaborate cross-functionally and externally with vendors. The individual for this position will be responsible for the compilation of labeling documents for all submissions which include labeling information to market Humacyte’s Human Acellular Vessel (HAV) in the US and worldwide. This position will also be accountable for completing tasks in regulatory operations.
Remote Work Designation : Onsite/Not Remote
Major Accountabilities:
This individual will be responsible for working closely with the scientific, regulatory, medical, and commercial/marketing functions to generate, proof-read, and manage versions of labeling documents.
Liaison with Regulatory, CMC, Marketing, Operations and Sales to manage changing properties to support labeling change projects including launches, promotions and packaging updates.
Manage advertising and marketing material changes to ensure accuracy and regulatory compliance.
Prepare and support regulatory submissions for product development, approvals and renewals for FDA and EMA.
Support regulatory submission of promotional materials.
Work closely with external vendors for timely generation, and review of SPL label format for labeling submissions.
This position may also support efforts within the company to improve labeling processes e.g., drafting of relevant SOPs, work instructions, generating templates etc.
Qualifications:
Requires a Bachelor’s degree, or equivalent on the job experience.
Six years of Regulatory Affairs work experience is required.
Minimum of 4 years of direct hand-on experience with global labeling document required, with US focus. Global experience preferred.
Experience working with Regulatory Operations required.
Proficient in working with the Electronic Common Technical Document (eCTD) and regulatory document management systems.
General Competencies:
Able to communicate effectively in English, both verbally and in writing
Excellent communication and interpersonal skills
Possess a positive roll-up-the-sleeves attitude and optimistic outlook
Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
Excellent organizational and time management skills with ability to set own priorities in a timely manner
High degree of flexibility and adaptability
Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
Must be able to work as needed to meet tight deadlines and at peak periods
Self-motivated and organized critical thinker with solid interpersonal and business communication skills
Demonstrated ability to work in a cross-functional team environment
Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
Ensures Humacyte or other required trainings/certifications are up to date
Represents the organization in a positive and professional manner
Reports to work on time and as scheduled
Apr 24, 2024
Full time
Humacyte, Inc. is bringing to market a once in a generation scientific technology platform, bioengineering readily available and universally implantable product opportunities focused on improving lives of patients and transforming the practice of medicine. Located in Durham, NC, the company develops and manufactures acellular tissues for the treatment of diseases and conditions across a wide range of therapeutic areas. The company’s innovative technology supports tissue repair, reconstruction, and replacement while overcoming limitations in existing standards of care. Initially developing a portfolio of human acellular vessels (HAVs), to target multiple vascular markets including trauma, arteriovenous access for hemodialysis, peripheral arterial disease, and coronary artery bypass grafting. Humacyte is also focused on the development of future markets such as pediatric heart surgery, delivery of cellular therapies, and multiple other novel cell and tissue systems.
We are looking for additional colleagues to continue to build our expanding team. Candidates will be expected to work both independently and collaboratively as part of the Humacyte organization. Applicants must be highly self-motivated, with solid communication skills, and demonstrates the ability to work in a team environment and lead other professionals and peers.
Position Background:
We are searching for a Manager, Regulatory Affairs Labeling and Operations with a solutions oriented, roll-up-your-sleeves, attitude to join the Regulatory Affairs team, collaborate cross-functionally and externally with vendors. The individual for this position will be responsible for the compilation of labeling documents for all submissions which include labeling information to market Humacyte’s Human Acellular Vessel (HAV) in the US and worldwide. This position will also be accountable for completing tasks in regulatory operations.
Remote Work Designation : Onsite/Not Remote
Major Accountabilities:
This individual will be responsible for working closely with the scientific, regulatory, medical, and commercial/marketing functions to generate, proof-read, and manage versions of labeling documents.
Liaison with Regulatory, CMC, Marketing, Operations and Sales to manage changing properties to support labeling change projects including launches, promotions and packaging updates.
Manage advertising and marketing material changes to ensure accuracy and regulatory compliance.
Prepare and support regulatory submissions for product development, approvals and renewals for FDA and EMA.
Support regulatory submission of promotional materials.
Work closely with external vendors for timely generation, and review of SPL label format for labeling submissions.
This position may also support efforts within the company to improve labeling processes e.g., drafting of relevant SOPs, work instructions, generating templates etc.
Qualifications:
Requires a Bachelor’s degree, or equivalent on the job experience.
Six years of Regulatory Affairs work experience is required.
Minimum of 4 years of direct hand-on experience with global labeling document required, with US focus. Global experience preferred.
Experience working with Regulatory Operations required.
Proficient in working with the Electronic Common Technical Document (eCTD) and regulatory document management systems.
General Competencies:
Able to communicate effectively in English, both verbally and in writing
Excellent communication and interpersonal skills
Possess a positive roll-up-the-sleeves attitude and optimistic outlook
Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
Excellent organizational and time management skills with ability to set own priorities in a timely manner
High degree of flexibility and adaptability
Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
Must be able to work as needed to meet tight deadlines and at peak periods
Self-motivated and organized critical thinker with solid interpersonal and business communication skills
Demonstrated ability to work in a cross-functional team environment
Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
Ensures Humacyte or other required trainings/certifications are up to date
Represents the organization in a positive and professional manner
Reports to work on time and as scheduled
Position Background:
The Automation Engineer 2 is responsible for supporting any existing and new project automation systems at Humacyte, an FDA regulated site. This includes daily verifications required for data integrity requirements and modifications to the system configuration as required for process, building or historian automation requirements. There is an expectation that the employee will have a primary system responsibility, either DeltaV, PLC, BAS, or PI focused, but will be able to support all automation system as required .
Remote Work Designation : Not Remote
Major Accountabilities:
Utilizing current engineering skills and knowledge, provide routine automation expertise for the development of custom commercial manufacturing equipment for a human acellular vessel product with the guidance and direction of more senior team members and/or manager
Support and maintain existing PI data historian in existing manufacturing and R&D facilities
In collaboration with Senior Automation Engineer and/or Associate Director, Automation, support the installation and validation of a PI data historian for the commercial manufacturing facility
Support the installation and validation of a DeltaV system for the commercial manufacturing process
Support the installation and validation a building automation system for the commercial manufacturing facility
Support the installation and validation of OEM and custom PLCs for the commercial manufacturing process
Assist process development team in testing prototype equipment and by independently developing automation for custom research and development equipment
Promote transparency around process development activities through routine internal updates to direct manager and/or cross-functional colleagues
Support and troubleshooting automation during development, technology transfer, and commercial manufacturing
Perform thorough system tests to ensure robustness of custom automation
Assist in oversight in transition of automated equipment to comply with regulatory and quality control requirements
Assist in the development of automation documentation, including functional requirements, design documents, test protocols, SOPs and reports
Respond to automation-based alarms during standard office hours and as on-call support, as required
Support regulatory filings as required
Other duties, as assigned
Special Competencies:
Demonstrated knowledge and understanding of developing and supporting automation for commercial manufacturing processes
Familiarity with automation of bioprocess applications in GMP facility
Familiarity and understanding of basic and/or advanced cGMP compliance in the biotech/bioprocessing manufacturing environment
Knowledge of Code of Federal Regulations 21 CFR 1271 a plus
Detail-oriented, self-motivated and scientifically driven
Strong analytical and problem-solving skills
Strong knowledge of GMP quality systems
Excellent communication and interpersonal skills
General Competencies:
Able to communicate effectively in English, both verbally and in writing
Excellent communication and interpersonal skills
Possess a positive roll-up-the-sleeves attitude and optimistic outlook
Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
Excellent organizational and time management skills with ability to set own priorities in a timely manner
High degree of flexibility and adaptability
Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
Must be able to work as needed to meet tight deadlines and at peak periods
Self-motivated and organized critical thinker with solid interpersonal and business communication skills
Demonstrated ability to work in a cross functional team
Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
Always observe safety precautions and regulations in all areas where duties are performed
Responsible for reporting all safety hazards and potential unsafe working conditions
Ensures Humacyte or other required trainings/certifications are up to date
Represents the organization in a positive and professional manner
Reports to work on time and as scheduled
Qualifications:
BS in Mechanical Engineering, Electrical Engineering, Chemical Engineering, or similar field, required
At least 3 years of industry experience in process and equipment automation
At least 3 years of relevant pharma or biotech industry experience
Experience with automation platforms including Allen-Bradley PLC, DeltaV DCS, Beckhoff TwinCAT PLC and/or Johnson Controls
Experience installing and/or supporting PI historian system
Background in Automation, Electrical Engineering or Mechanical Engineering
Knowledge and experience with standard bioprocessing skills as well as use and maintenance of common laboratory procedures and equipment
Will spend time in a clean room environment for manufacturing operations and will be required to meet applicable gowning and personal protective equipment guidelines
Apr 24, 2024
Full time
Position Background:
The Automation Engineer 2 is responsible for supporting any existing and new project automation systems at Humacyte, an FDA regulated site. This includes daily verifications required for data integrity requirements and modifications to the system configuration as required for process, building or historian automation requirements. There is an expectation that the employee will have a primary system responsibility, either DeltaV, PLC, BAS, or PI focused, but will be able to support all automation system as required .
Remote Work Designation : Not Remote
Major Accountabilities:
Utilizing current engineering skills and knowledge, provide routine automation expertise for the development of custom commercial manufacturing equipment for a human acellular vessel product with the guidance and direction of more senior team members and/or manager
Support and maintain existing PI data historian in existing manufacturing and R&D facilities
In collaboration with Senior Automation Engineer and/or Associate Director, Automation, support the installation and validation of a PI data historian for the commercial manufacturing facility
Support the installation and validation of a DeltaV system for the commercial manufacturing process
Support the installation and validation a building automation system for the commercial manufacturing facility
Support the installation and validation of OEM and custom PLCs for the commercial manufacturing process
Assist process development team in testing prototype equipment and by independently developing automation for custom research and development equipment
Promote transparency around process development activities through routine internal updates to direct manager and/or cross-functional colleagues
Support and troubleshooting automation during development, technology transfer, and commercial manufacturing
Perform thorough system tests to ensure robustness of custom automation
Assist in oversight in transition of automated equipment to comply with regulatory and quality control requirements
Assist in the development of automation documentation, including functional requirements, design documents, test protocols, SOPs and reports
Respond to automation-based alarms during standard office hours and as on-call support, as required
Support regulatory filings as required
Other duties, as assigned
Special Competencies:
Demonstrated knowledge and understanding of developing and supporting automation for commercial manufacturing processes
Familiarity with automation of bioprocess applications in GMP facility
Familiarity and understanding of basic and/or advanced cGMP compliance in the biotech/bioprocessing manufacturing environment
Knowledge of Code of Federal Regulations 21 CFR 1271 a plus
Detail-oriented, self-motivated and scientifically driven
Strong analytical and problem-solving skills
Strong knowledge of GMP quality systems
Excellent communication and interpersonal skills
General Competencies:
Able to communicate effectively in English, both verbally and in writing
Excellent communication and interpersonal skills
Possess a positive roll-up-the-sleeves attitude and optimistic outlook
Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
Excellent organizational and time management skills with ability to set own priorities in a timely manner
High degree of flexibility and adaptability
Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
Must be able to work as needed to meet tight deadlines and at peak periods
Self-motivated and organized critical thinker with solid interpersonal and business communication skills
Demonstrated ability to work in a cross functional team
Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
Always observe safety precautions and regulations in all areas where duties are performed
Responsible for reporting all safety hazards and potential unsafe working conditions
Ensures Humacyte or other required trainings/certifications are up to date
Represents the organization in a positive and professional manner
Reports to work on time and as scheduled
Qualifications:
BS in Mechanical Engineering, Electrical Engineering, Chemical Engineering, or similar field, required
At least 3 years of industry experience in process and equipment automation
At least 3 years of relevant pharma or biotech industry experience
Experience with automation platforms including Allen-Bradley PLC, DeltaV DCS, Beckhoff TwinCAT PLC and/or Johnson Controls
Experience installing and/or supporting PI historian system
Background in Automation, Electrical Engineering or Mechanical Engineering
Knowledge and experience with standard bioprocessing skills as well as use and maintenance of common laboratory procedures and equipment
Will spend time in a clean room environment for manufacturing operations and will be required to meet applicable gowning and personal protective equipment guidelines