EPM Scientific
Please note: Applicants must hold an EU passport or existing right to work in the EU (no sponsorship available). Fluency in French or Dutch is mandatory.
A leading pharmaceutical/biotech organisation is seeking an experienced
Computer System Validation (CSV) Consultant
to support critical projects in compliance with
GAMP 5
guidelines. This role offers the opportunity to contribute to high-impact initiatives within a regulated environment, ensuring systems meet stringent quality and compliance standards. Key Responsibilities Lead and execute CSV activities in alignment with GAMP 5 and regulatory requirements Develop, review, and approve validation documentation (URS, FS, DS, IQ, OQ, PQ, traceability matrices) Partner with QA, IT, and business stakeholders to ensure compliance and audit readiness Support system lifecycle management, including risk assessments and change control Provide expertise during regulatory inspections and internal audits Requirements Minimum 5 years' experience in Computer System Validation within pharma/biotech Strong knowledge of
GAMP 5
and EU GMP Annex 11/21 CFR Part 11 compliance Proven track record of delivering CSV projects in regulated environments Fluency in French or Dutch EU passport or existing right to work in the EU required
(no sponsorship available) Ability to work on-site in
France or the Netherlands What's on Offer 12-month freelance contract
with competitive day rate Opportunity for
permanent employment
for the right candidate Work on-site with a global leader in the life sciences sector Collaborative, international environment with high visibility projects
Computer System Validation (CSV) Consultant
to support critical projects in compliance with
GAMP 5
guidelines. This role offers the opportunity to contribute to high-impact initiatives within a regulated environment, ensuring systems meet stringent quality and compliance standards. Key Responsibilities Lead and execute CSV activities in alignment with GAMP 5 and regulatory requirements Develop, review, and approve validation documentation (URS, FS, DS, IQ, OQ, PQ, traceability matrices) Partner with QA, IT, and business stakeholders to ensure compliance and audit readiness Support system lifecycle management, including risk assessments and change control Provide expertise during regulatory inspections and internal audits Requirements Minimum 5 years' experience in Computer System Validation within pharma/biotech Strong knowledge of
GAMP 5
and EU GMP Annex 11/21 CFR Part 11 compliance Proven track record of delivering CSV projects in regulated environments Fluency in French or Dutch EU passport or existing right to work in the EU required
(no sponsorship available) Ability to work on-site in
France or the Netherlands What's on Offer 12-month freelance contract
with competitive day rate Opportunity for
permanent employment
for the right candidate Work on-site with a global leader in the life sciences sector Collaborative, international environment with high visibility projects