Job Title: CQV Project Lead – Facilities and Utilities
Job ID: 546
City: Wakefield
State: Massachusetts
Job Type: FT On-Site/PT On-Site/FT Remote/PT Remote/FT Hybrid/PT Hybrid
Position Overview:
The CQV Project Lead – Facilities and Utilities is responsible for overseeing the commissioning, qualification, and validation (CQV) of facility infrastructure and utility systems critical to life sciences environments. This role ensures compliance with regulatory standards and internal quality requirements, focusing on systems essential for maintaining operational efficiency and product safety.
Key Responsibilities:
- Lead CQV activities for facilities and utilities, including HVAC, VHP, clean utilities, and cold storage (refrigerators, freezers, walk-in cold rooms).
- Develop and execute protocols for Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Collaborate with cross-functional teams to ensure smooth project delivery and regulatory compliance for facility spaces.
- Provide technical expertise for maintaining critical environmental and storage conditions.
Required Qualifications:
- Bachelor’s degree in Life Sciences, Engineering, or related field.
- 5+ years of experience in facilities/utilities CQV within life sciences.
- Knowledge of HVAC systems, cleanroom validation, and regulatory requirements for facilities and utilities.