CSV Consultant Job at EPM Scientific, Princeton, NJ

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  • EPM Scientific
  • Princeton, NJ

Job Description

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

Job Tags

Permanent employment, Contract work, Freelance,

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