Sr. QAV Specialist

Target PR Range: 74-84/hr DOE

Provide onsite QAV support at 170 Middlesex Turnpike Gene Therapy Manufacturing facility located in Bedford, MA to support the following QAV activities for the AM805 tech transfer project:

• Review and approval of equipment, automation, facility, and utility system validation lifecycle documents for the AM805 tech transfer project, including but not limited to:
  • SLRA (System Level Risk Assessments)
  • DI (Data Integrity) Assessments
  • DR/DQ
  • Specifications
  • IQ/OQ/PQ Qualification Protocols
  • Validation Issues
  • IQ/OQ/PQ Qualification Reports
  • Risk assessments
• Review and approval of BMRAM work orders for equipment, automation, facilities, and utilities.
• Independently represent QAV in cross‑functional project meetings.

• A B.S. degree in Engineering or other science field such as microbiology, chemistry, or biochemistry.
• Experience in biopharmaceutical or biotechnology-based GMP operations with experience in Quality and/or Validation roles.
• Direct experience with facility, equipment, and utility validation is required. Experience with cell culture and single-use systems is preferred.
• Knowledge of relevant FDA and EMA regulations.
• Ability and willingness to work in a fast-paced environment that will require a combination of individual contribution, documentation reviews, and communication of quality requirements aligned with program procedures in cross‑functional meetings.
• Excellent oral and written communication skills with strong technical writing experience are required.
• Excellent organizational skills and attention to detail.
• Experience with continuous improvement efforts.