12 Engineering jobs

Performs cradle-to-grave contracting actions including acquisition planning, solicitation, evaluation and cost/price analyses, negotiations, contract award, modifications/amendments, terminations, closeouts, and contractor performance reviews. Performs Pre- and Post-Award functions for a wide variety of highly complex procurements and contracts that are unusual, unique, non-routine or otherwise difficult to accomplish. Performs market research, identifies potential vendors, evaluates offers, performs comparative price analysis for reasonableness, and recommends award of contracts. Negotiates settlements for contractual changes. Negotiates equitable adjustments and supplemental agreements to delivery or performance time and prices, and execution of supplemental agreements for reduced or additional requirements. Provides guidance or training to lower grades, new hires, or others as necessary. Serves as a Warranted Contracting Officer based on the needs of the assigned Supply Chain.    

Performs preliminary engineering analysis based upon general identification of needs requirements. Conducts in-depth site surveys to determine condition of structures and systems. Formulates general project estimates and develops broad scope of work. Monitors overall schedules and milestones upon award of construction contract. Serves as technical advisor to Engineering Technicians and building managers. Studies and evaluates existing building structure and systems for deficiencies in performance (e.g. roofing, mechanical, etc)    

As a Transportation Engineer in the Federal Highway Administration (FHWA) Ohio Federal-aid division office you will be responsible for providing advice and guidance on Federal laws, regulations, and FHWA policies applicable to Federal-aid highway projects within the State DOT project development process, in meetings, telephone contacts, public hearings, field reviews, and visits with State DOT officials and other Federal, State, and local agencies. You will conduct project reviews including a review of required project actions for appropriate application of design standards and criteria, conformance with policy and regulations, eligibility for Federal participation, traffic safety features, reasonableness of cost estimates, fulfillment of requirements from the transportation planning and contract provisions. You will authorize project agreements which may include reviewing the adequacy of proposed rights-of-way clearances, NEPA, construction plans, agreements for utility and railroad work, consultant agreements.  You will participate in and contribute to Division program management activities including development of stewardship and oversight plans, conducting risk assessments, development of strategic operations and business plans.   The ideal candidate for this position  is an engineer with experience monitoring Federally funded highway programs or delivering highway projects from initial scoping through construction support and maintenance and experience conveying ideas and concepts to persuade others in meetings, discussions, and in writing. Your resume must contain sufficiently detailed information describing your work experience applicable to this position’s primary duties and responsibilities for us to make a qualification determination. Also, ensure that your resume contains specific information such as position titles, beginning and ending dates of employment for each position, average number of hours worked per week, and if the position is/was in the Federal government, you should provide the position series and grade level.

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 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.

Knowledge of Revit, AutoCAD, RISA 3D & MS Office. Produce design drawings. The position requires specification writing/editing abilities. Preparation of equipment bid packages, shop drawings, review and report writing. Interaction and coordinate with clients, vendors, co-workers, other disciplines, and departments as necessary to coordinate and effectively communicate project design goals, needs and overall status. Provide filed assistance and front-end information gathering at project sites when needed. Must be able to work in a project team and maintain a project schedule, be a self-starter, detailed oriented and have exceptional organizational skills. Must be able to interact with clients and co-workers in a professional and respectful manner and work in a team environment sharing roles and responsibilities with limited supervision. Industrial and construction field is a plus!

Knowledge of Revit, AutoCAD, RISA 3D & MS Office. Produce design drawings. The position requires specification writing/editing abilities. Preparation of equipment bid packages, shop drawings, review and report writing. Interaction and coordinate with clients, vendors, co-workers, other disciplines, and departments as necessary to coordinate and effectively communicate project design goals, needs and overall status. Provide filed assistance and front-end information gathering at project sites when needed.   Must be able to work in a project team and maintain a project schedule, be a self-starter, detailed oriented and have exceptional organizational skills. Must be able to interact with clients and co-workers in a professional and respectful manner and work in a team environment sharing roles and responsibilities with limited supervision.   Industrial and construction field is a plus!

Knowledge of Revit, AutoCAD, RISA 3D & MS Office. Produce design drawings. The position requires specification writing/editing abilities. Preparation of equipment bid packages, shop drawings, review and report writing. Interaction and coordinate with clients, vendors, co-workers, other disciplines, and departments as necessary to coordinate and effectively communicate project design goals, needs and overall status. Provide filed assistance and front-end information gathering at project sites when needed. Must be able to work in a project team and maintain a project schedule, be a self-starter, detailed oriented and have exceptional organizational skills. Must be able to interact with clients and co-workers in a professional and respectful manner and work in a team environment sharing roles and responsibilities with limited supervision.   Industrial and construction field is a plus!

Knowledge of Revit, AutoCAD, RISA 3D & MS Office. Produce design drawings. The position requires specification writing/editing abilities. Preparation of equipment bid packages, shop drawings, review and report writing. Interaction and coordinate with clients, vendors, co-workers, other disciplines, and departments as necessary to coordinate and effectively communicate project design goals, needs and overall status. Provide filed assistance and front-end information gathering at project sites when needed. Must be able to work in a project team and maintain a project schedule, be a self-starter, detailed oriented and have exceptional organizational skills. Must be able to interact with clients and co-workers in a professional and respectful manner and work in a team environment sharing roles and responsibilities with limited supervision. Industrial and construction field is a plus!  

Knowledge of Revit, AutoCAD, RISA 3D & MS Office. Produce design drawings. The position requires specification writing/editing abilities. Preparation of equipment bid packages, shop drawings, review and report writing. Interaction and coordinate with clients, vendors, co-workers, other disciplines, and departments as necessary to coordinate and effectively communicate project design goals, needs and overall status. Provide filed assistance and front-end information gathering at project sites when needed. Must be able to work in a project team and maintain a project schedule, be a self-starter, detailed oriented and have exceptional organizational skills. Must be able to interact with clients and co-workers in a professional and respectful manner and work in a team environment sharing roles and responsibilities with limited supervision. Industrial and construction field is a plus!

Knowledge of Revit, AutoCAD, RISA 3D & MS Office. Produce design drawings. The position requires specification writing/editing abilities. Preparation of equipment bid packages, shop drawings, review and report writing. Interaction and coordinate with clients, vendors, co-workers, other disciplines, and departments as necessary to coordinate and effectively communicate project design goals, needs and overall status. Provide filed assistance and front-end information gathering at project sites when needed. Must be able to work in a project team and maintain a project schedule, be a self-starter, detailed oriented and have exceptional organizational skills. Must be able to interact with clients and co-workers in a professional and respectful manner and work in a team environment sharing roles and responsibilities with limited supervision.   Industrial and construction field is a plus!

Knowledge of Revit, AutoCAD, RISA 3D & MS Office. Produce design drawings. The position requires specification writing/editing abilities. Preparation of equipment bid packages, shop drawings, review and report writing. Interaction and coordinate with clients, vendors, co-workers, other disciplines, and departments as necessary to coordinate and effectively communicate project design goals, needs and overall status. Provide filed assistance and front-end information gathering at project sites when needed. Must be able to work in a project team and maintain a project schedule, be a self-starter, detailed oriented and have exceptional organizational skills. Must be able to interact with clients and co-workers in a professional and respectful manner and work in a team environment sharing roles and responsibilities with limited supervision. Industrial and construction field is a plus!