US - CQV Consultant
On-siteBoston, Massachusetts, United States
Job Summary
Write C/Q/V documents including Master Plans, Commissioning Forms, Protocols, SOPs, and FATs/SATs following established standards. Review protocols, executed records, and reports for commissioning and validation activities to ensure compliance with quality policies and regulatory requirements. Lead CQV efforts for biopharmaceutical manufacturing systems, including CIP/SIP, fermentation, and purification, while providing technical assistance during investigations of process, equipment, or cleaning issues. Perform the role of Validation Representative for Change Control Requests and CAPAs, compile data for completed activities, and assist in resolving validation deviations and non-conformances. Travel will be required. Candidates must be eligible to work in the US.
Required Qualifications
- Bachelor's Degree in Engineering, preferably Chemical or Biotechnology
- 3-4+ years of experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation or QA
- Experience in writing and execution of VMP, FQ, IQ, OQ and PQ forms and protocols for GMP Utilities, Equipment, Systems and Software
- Must have experience with qualifying clean utilities, HVAC System, Vaccine production equipment, production facilities and environmental validation
- Must have experience with field execution of functionality testing, alarms and safety testing and integrated system testing
- Must be eligible to work in the US for any employer
- Travel will be required
Desired Qualifications
- Experience in industrial automation and system controls is a plus
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