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Automation Engineer

All Openings | Research Triangle Park, NC | Full Time

Job Description

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 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:

The Automation Engineer will be expected to work both independently and collaboratively as part of the Humacyte organization. Candidates must be highly self-motivated, with solid communication skills, and demonstrate the ability to work in a team environment, and lead other professionals and peers.

 Position reports to Associate Director, Automation

Primary Responsibilities:

  • Provide automation expertise for the development of custom commercial manufacturing equipment for a human acellular vessel product
  • Support and maintain an existing PI data historian in existing manufacturing and R&D facilities
  • 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
  • Support and troubleshooting automation during development, technology transfer, and commercial manufacturing
  • Perform thorough system tests to ensure robustness of custom automation
  • Oversee 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
  • Support regulatory filings as required
  • 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
  • Detail-oriented, self-motivated and scientifically driven
  • Motivated and organized critical thinker with solid interpersonal and communication skills
  • Strong analytical and problem-solving skills
  • Demonstrated ability to work in a cross functional team
  • Routinely communicate findings and information to other team members; transparency and knowledge sharing is expected and practiced
  • Must be able to work as needed to meet tight deadlines and at peak periods

Special Competencies:

  • Demonstrated expertise in 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
  • Strong analytical and problem solving skills
  • Strong knowledge of GMP quality systems
  • Detail-oriented, self-motivated and scientifically driven

QUALIFICATIONS:

  • BS in Mechanical Engineering, Electrical Engineering, Chemical Engineering, or similar field
  • 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

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.**