CQV Engineer II

1 week ago

Durham, North Carolina, United States Humacyte Full time

The CQV Engineer II will be responsible for writing, execution, and summary of commissioning, qualification, and verification protocols related to facility, utilities, laboratory instruments, manufacturing equipment, and computerized systems. They will support the development of URS, FRS, CS, DS, 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).

Requirements

  • 3 years of direct commissioning, qualification, validation, and/or verification experience, required.
  • 4+ years of pharmaceutical / biotech experience preferred.
  • Bachelor's degree, required, preferably in a technical program such as Engineering, mathematics, or a scientific based field.
  • Will spend a portion of time in clean room environment to perform validation activities and will be required to meet applicable gowning and personal protective equipment guidelines.
  • 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.

Major Accountabilities

  • Support activities related to commissioning, qualification, and verification 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.
  • 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 verification 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.

Specific Skills

  • Results oriented, self-motivated, self-starter with flexibility to adapt to changing priorities and ability to manage up to 5 projects/activities simultaneously.
  • Ability to interact with various individuals and roles throughout the organization.
  • Strong working knowledge of good documentation practices and FDA, EudraLex, and other regulatory agency regulations and guidance, preferred.
  • Strong ability and willingness to learn and work within a team environment, required.
  • Specialized or strong experiences in 1 of the following areas:
  • Facilities and utilities
  • Laboratory instruments
  • Manufacturing equipment
  • Automation systems
  • Computerized Systems
  • Periodic Reviews

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