Job Title: CQV Project Lead – Manufacturing Systems
Job ID: 547
City: Wakefield
State: Massachusetts
Job Type: Full Time On-Site/Full Time Remote/Part Time On-Site/Part Time Remote/Full Time Hybrid
Position Overview:
As a CQV Project Lead for Manufacturing Systems, you will oversee the commissioning, qualification, and validation (CQV) of life sciences manufacturing equipment and environments. Your role ensures that all manufacturing suites and equipment meet regulatory standards, focusing on maintaining product integrity and process reliability.
Key Responsibilities:
- Lead CQV efforts for manufacturing systems including HVAC, BSCs, LFHs, autoclaves, parts washers, and single-use equipment (mixers, bioreactors).
- Execute CQV protocols for Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Ensure validation of laboratory equipment (bench scales, pH meters, Vi-Cell analyzers) to support manufacturing processes.
- Work closely with cross-functional teams to integrate CQV processes into daily manufacturing operations.
- Bachelor’s degree in Life Sciences, Engineering, or related field.
- 5+ years of experience in manufacturing CQV in life sciences.
- Knowledge of aseptic manufacturing practices, single-use systems, and GMP requirements.