Lab CSV Consultant

I'm recruiting on behalf of a pharmaceutical manufacturing client in Oregon for an experienced Computer System Validation (CSV) Consultant to join their site on a contract basis. This is a fully onsite position with a minimum 12 month commitment, supporting validation activities across lab based GxP systems.

• Develop and execute CSV protocols including IQ, OQ, and PQ for lab based computerized systems
• Author and review Validation Plans, User Requirements Specifications, Functional Specifications, and Risk Assessments
• Support validation of systems such as LIMS, Empower, chromatography data systems, and other analytical or QC lab software
• Ensure compliance with 21 CFR Part 11, Annex 11, and applicable data integrity requirements
• Manage deviations, change controls, and CAPAs related to computer system validation
• Liaise with QA, QC, and IT teams to ensure validation deliverables meet site and regulatory expectations
• Support audit readiness and participate in internal and external inspections as needed

• Minimum 5 years of CSV experience within pharmaceutical or biotech, ideally within a QC or analytical lab environment
• Strong working knowledge of 21 CFR Part 11, Annex 11, and GAMP 5
• Hands on experience validating LIMS, Empower, or other chromatography data systems
• Solid understanding of data integrity principles and CSA/CSV methodologies
• Strong documentation and technical writing skills
• Must be based in or willing to relocate to Oregon for the full duration of the contract, fully onsite