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Process Engineer I (MSAT)

All Openings | Research Triangle Park, NC | Full Time

Job Description

**Please note, Humacyte does not provide sponsorship at this time.**

Humacyte, Inc., a biotechnology pioneer, discovers, develops and delivers innovative, award winning human biotherapies.  We are currently developing multiple vascular tissue engineered therapies and expanding our business model.  With a broad pipeline of potential new therapy applications, we continue to build our organization and scientific teams.  We are looking for additional biomedical research and development 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:

Position will support the development and execution of product lifecycle management and process analytics activities. This role will work closely with personnel in Process Development, Manufacturing, Engineering, Quality Assurance, and Quality Control.

Position reports to VP, Commercial Manufacturing

Primary Responsibilities:

  • Support execution and development of the manufacturing control strategy and Process Analytics program.
  • Acquire, analyze, and report data trends using graphical and statistical methods
  • Support technology transfer and process validation of products into commercial manufacturing
  • Author standard operating procedures, reports, and protocols
  • Become a process expert on the HAV manufacturing process, systems, and equipment
  • Support troubleshooting, non-conformance investigation, and change control management activities.
  • Assist in development and implementation of process specifications, parameters, operating ranges, and action limits.
  • Provide guidance to others on 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
  • Other duties, as assigned

General Competencies:

  • Possess a positive 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
  • Strong communication (verbal and written) and organizational skills
  • Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
  • Motivated and organized critical thinker with solid interpersonal and business communication skills
  • Demonstrated ability to work effectively within a team to set goals, develop sound project plans, monitor progress, and report results scientifically
  • Routinely communicate findings and information to other team members; transparency and knowledge sharing is expected and practiced

Special Competencies:

  • Able to troubleshoot bioprocess activities and perform typical bioprocess optimization studies
  • Possesses knowledge of the cell biological aspects of the process, as well as the engineering and mass-transfer aspects of the process
  • Possesses understanding of equipment and procedures and identifies potential problem before they occur
  • Knowledge of statistical process control charts and data interpretation
  • Demonstrated technical foundation of cell- and tissue- based products and a familiarity with GMP manufacturing
  • Familiar with technical and engineering operations of scaled cell culture systems
  • Familiar with feedback control and monitoring of relevant process gasses, nutrients, biological waste products in mammalian cell systems
  • Able to develop solutions and implement process improvements to manufacturing issues by way of corrective and preventative actions (CAPAs)
  • Highly motivated and organized
  • Familiarity and understanding of foundational and/or advanced cGMP compliance in the biotech/bioprocessing manufacturing environment.  Knowledge of Code of Federal Regulations 21 CFR 1271 a plus

QUALIFICATIONS:

  • BS in engineering or relevant field, required
  • 0 – 2 years of industry experience in bioprocessing and engineering.
  • Background chemical engineering, biochemical engineering, biotechnology, bioprocessing, cell technology, biomedical engineering, cell therapy, tissue engineering, regenerative medicine, and/or cell biology
  • Background in cellular bioprocessing and cell culture development a plus
  • Proficiency with statistical methods for data analysis and hypothesis testing a plus
  • Experience with cell culture operations, specifically using adherent mammalian cells

Perks:

  • Stock Options
  • 401k Plan with Matching
  • Medical, Vision and Dental Plans
  • Long Term/Short Term Disability
  • Life Insurance
  • 23 Days Paid Time Off (PTO)
  • 11 Paid Holidays
  • Paid Parental Leave Policies

**Please note, Humacyte does not provide sponsorship at this time.**