CQV Engineer II​/III

COMPANY: Humacyte Inc (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s initial opportunity, a portfolio of Acellular Tissue Engineered Vessel (ATEVs), is currently approved for use in vascular trauma repair and is in late-stage clinical trials targeting multiple other applications including AV access for hemodialysis and peripheral arterial disease.

Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma also received the RMAT designation.

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The CQV Engineer II / III will be responsible for writing, execution, and summary of commissioning, qualification, and validation protocols related to local and enterprise based computerized systems, laboratory instruments, manufacturing equipment, and facility and utility-based systems. They will support the development of validation specifications, assessments and master plans. They will prepare and complete periodic reviews and requalifications in a timely manner.

All work to be conducted according to governing SOPs and cGMPs (current Good Manufacturing Practices).

• Support activities related to commissioning, qualification, and validation of facility, utilities, laboratory instruments, manufacturing equipment, and computerized systems
• Lead the creation and revision of validation assessments, including GAMP and electronic records and signatures assessments.
• Familiar with Kaye AVS and Veriteq temperature mapping systems
• Familiar with computerized maintenance management systems, (CMMS) like BMRAM.
• Take part in the development and revision of validation specifications including URS, FRS, CS, and DS, as well as Trace Matrices.
• Assist in the development of project or system specific Validation Plans.
• Write, execute, and summarize commissioning, qualification, and validation protocols.
• Identify and support the resolution of protocol deviations noted during protocol execution and review.
• Assist in root cause analysis related to QA Deviations / Non-conformance events.
• Adheres to periodic review and requalification schedule for systems per procedure and established plans.
• Revise internal and external departmental procedures based on previously obtained CQV data.
• Present findings and results from completed CQV deliverables in internal and external audits specific to work which was performed firsthand.
• Represent the CQV team in internal meetings.
• Other Duties as assigned.

• 3 - 5 years of direct commissioning, qualification, and/or validation experience, required.
• 3 years of pharmaceutical / biotech experience preferred.
• Bachelor’s degree, required, preferably in a technical program such as Engineering, mathematics, or a scientific based field.
• Specialized or strong experiences in one of the following areas:
  • Site or enterprise based computerized systems
  • Laboratory instruments
  • Manufacturing equipment
  • Automation systems
  • Facility and utilities
  • Periodic Reviews
  • Temperature mapping equipment such as Kaye and Veriteq
• Strong working knowledge of good documentation practices and FDA, Eudra Lex, and other regulatory agency regulations and guidance, preferred.
• Ability to lift up to 20 pounds, required.
• Willingness to regularly, predictably, and reliably perform required functions at work, including occasional work outside typical office hours and weekends.
• Excellent communication and interpersonal skills.
• Possess a positive roll-up-the-sleeves attitude and optimistic…