What are the responsibilities and job description for the Lab CSV Consultant position at ARM International?
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.
Key Responsibilities
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
Requirements
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