Sr. QAV Specialist

Target PR Range: 74-84/hr DOE Responsibilities 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. Requirements 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. #J-18808-Ljbffr Planet Pharma