Senior MSAT/Process Engineer

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