Position Summary
We are seeking a Senior Commissioning, Qualification, and Validation (CQV) Engineer to support pharmaceutical and biopharmaceutical manufacturing projects. The ideal candidate has strong hands-on experience with upstream and downstream process equipment, including qualification planning, protocol development, field execution, and troubleshooting. Clean-in-Place (CIP) and Steam-in-Place (SIP) experience is a major plus.
Key Responsibilities
* Lead CQV activities for manufacturing equipment and process systems, from design review and commissioning through qualification and final turnover.
* Develop and review user requirements, risk assessments, commissioning plans, IQ/OQ/PQ protocols, traceability matrices, and qualification summary reports.
* Execute qualification of upstream equipment, including bioreactors, fermenters, seed-train systems, media preparation vessels, and associated transfer systems.
* Perform qualification of downstream equipment, including harvest systems, chromatography skids, filtration equipment, ultrafiltration/diafiltration systems, and buffer preparation vessels.
* Coordinate and support Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), equipment installation verification, and functional testing.
* Review P&IDs, equipment specifications, calibration records, vendor documentation, and turnover packages to confirm readiness for qualification.
* Work with Automation and Manufacturing teams to verify equipment sequences, process parameters, alarms, interlocks, and recipe functionality.
* Investigate protocol deviations, troubleshoot equipment issues, assess qualification impact, and coordinate corrective actions and retesting.
* Partner with Engineering, Manufacturing, Quality Assurance, and equipment vendors to resolve technical issues and meet project milestones.
* Maintain accurate, complete qualification documentation in accordance with site procedures, cGMP expectations, and good documentation practices.
Required Qualifications
* Bachelor’s degree in Chemical, Mechanical, Biochemical Engineering, Biotechnology, or a related discipline, or equivalent relevant experience.
* Demonstrated senior-level CQV experience in pharmaceutical or biopharmaceutical manufacturing.
* Hands-on experience qualifying both upstream and downstream process equipment.
* Strong experience authoring and executing IQ/OQ/PQ protocols and resolving qualification deviations.
* Ability to interpret engineering drawings, equipment specifications, and process control documentation.
* Strong technical writing, troubleshooting, communication, and project coordination skills.
* Ability to work onsite in Vacaville, California.
Strongly Preferred Experience
* Hands-on CIP and SIP cycle development, qualification, and troubleshooting.
* Experience with cleaning cycle verification, SIP temperature mapping, and sterilization cycle studies.
* Experience with stainless-steel and single-use processing systems, sanitary piping, and hygienic equipment design.
* Experience supporting facility start-ups, equipment installations, or manufacturing expansion projects.
