Senior Pharmaceutical CQV Engineer
- Permanent
Pharmaceutical Senior CQV Engineer
Visium Resources has been asked to identify qualified candidates for this Pharmaceutical Senior CQV Engineer position. This position is a direct hire which is expected to be on-site in Boulder, CO.
We are seeking a highly motivated Senior CQV Engineer to support commissioning, qualification, and validation activities for pharmaceutical and biotechnology manufacturing facilities. The successful candidate will lead and execute CQV deliverables associated with GMP-regulated process equipment, utilities, automation systems, cleanrooms, and manufacturing operations. This role requires hands-on technical expertise, strong project coordination skills, and a thorough understanding of FDA and cGMP compliance requirements. The Senior CQV Engineer will work cross-functionally with Engineering, Quality, Manufacturing, Automation, and external vendors to ensure successful project execution and operational readiness within fast-paced life sciences environments.
Key Responsibilities
- Lead and execute CQV activities for pharmaceutical and biotech capital projects.
- Develop and execute: commissioning plans, IQ/OQ/PQ protocols, validation test scripts, traceability matrices, summary reports.
- Support startup and qualification of: process equipment, clean utilities, HVAC systems, manufacturing suites, automation and control systems.
- Coordinate field execution activities with engineering, construction, vendors, and operations teams.
- Perform system walkdowns and turnover package reviews.
- Support deviation investigations, CAPAs, and change control activities.
- Ensure all validation documentation complies with cGMP, FDA, ISPE, and GAMP guidelines.
- Participate in FAT/SAT execution and acceptance activities.
- Support project schedule development and milestone tracking.
- Collaborate with Quality Assurance and Manufacturing teams to support inspection readiness and successful system release.
- Mentor junior CQV engineers and validation specialists as needed.