Sr. QAV Specialist

Responsibilities

• 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.
• 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 is required.
• Excellent organizational skills and attention to detail.
• Experience with continuous improvement efforts.