CQV Engineer

CQV Engineer – Pharmaceutical CDMO Project

Location: Waltham, MA

Employment Type: Full-Time

We are seeking an experienced CQV (Commissioning, Qualification, and Validation) Engineer to support a pharmaceutical CDMO project in Waltham, MA. The CQV Engineer will be responsible for executing commissioning, qualification, and validation activities for GMP manufacturing equipment, utilities, facilities, and computerized systems in support of biologics and/or pharmaceutical manufacturing operations.

The ideal candidate will have hands‑on experience in regulated GMP environments and a strong understanding of FDA, cGMP, ISPE, and GAMP guidelines. This role requires close collaboration with engineering, manufacturing, quality assurance, validation, and project management teams to ensure systems are designed, installed, tested, and documented in compliance with regulatory and client requirements.

• Support commissioning and qualification activities for manufacturing equipment, utilities, clean rooms, and process systems.
• Execute and review IQ/OQ/PQ protocols and associated summary reports.
• Coordinate field execution activities with engineering, vendors, construction, and operations teams.
• Assist with startup and troubleshooting of GMP process equipment and utility systems.
• Ensure validation documentation complies with FDA, cGMP, ISPE Baseline Guides, and company SOPs.
• Perform walkdowns, punch list generation, and system turnover support.
• Support risk assessments, change controls, deviations, CAPAs, and investigations related to CQV activities.
• Review P&IDs, specifications, turnover packages, and vendor documentation.
• Participate in FAT/SAT execution and documentation review.
• Collaborate with Quality Assurance to ensure successful system release and readiness for GMP operations.
• Maintain accurate project documentation and provide status updates to project leadership.

• Bachelor’s degree in Engineering, Life Sciences, or related technical discipline.
• 5-10 years of CQV, validation, or commissioning experience within the pharmaceutical, biotech, or CDMO industry.
• Experience with GMP equipment such as bioreactors, CIP/SIP systems, autoclaves, filling lines, HVAC, clean utilities, or process skids preferred.
• Strong knowledge of cGMP regulations, FDA guidelines, GAMP 5, and ISPE commissioning/qualification practices.
• Experience authoring and executing validation lifecycle documentation.
• Ability to work independently in a fast‑paced project environment.
• Strong communication, technical writing, and organizational skills.
• Proficiency with Microsoft Office and electronic validation/document management systems.