Lab CSV Consultant

ARM International; Oregon (WI); On-site; USD 100,000 - 140,000; Full time

Job summary

ARM International is seeking an experienced Computer System Validation (CSV) Consultant for an onsite, 12+ month contract in Oregon. The role focuses on validating lab-based GxP systems, including LIMS and Empower, with emphasis on 21 CFR Part 11 compliance.

The candidate will author and review Validation Plans, user specifications, and risk assessments while coordinating with QA, QC, and IT to ensure inspections and audits are ready.

Qualifications

• 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.

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.

Skills

CSV experience

Regulatory knowledge

Documentation

Technical writing

Tools

LIMS

Empower

Job description

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