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Automation Specialist Pharma @ Employer

Leiden, NL363, NLOnsiteContract
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About this role

Automation Specialist Pharma (CSV-QA) - Laboratory, Engineering, Quality Assurance - Netherlands, Leiden - October 21, 2026 - Fulltime - BH-71509 - 4500-5000 Automation Specialist Pharma (CSV-QA) Leiden | Hybrid | Full-time | 1-year assignment Turn your automation expertise into reliable laboratory solutions. In this role, you'll combine hands-on technical work with non-conformance investigations to strengthen data integrity, resolve issues and keep pharmaceutical QC laboratories GMP-compliant.

What you'll do

  • Lead non-conformance investigations, identify root causes and drive corrective and preventive actions (CAPA).
  • Implement, maintain and troubleshoot laboratory systems, from analytical instruments to platforms connected to LIMS.
  • Safeguard data integrity, maintain technical documentation and support GMP and 21 CFR Part 11 compliance.
  • Collaborate across teams on automation projects, continuous improvement and audit readiness.

What you bring

  • A bachelor's degree (HBO) in Life Sciences, Computer Science or equivalent experience in a similar role.
  • At least 2 years of pharmaceutical industry experience with GMP and automation responsibilities, plus knowledge of QC compliance and FDA/EMA guidelines.
  • Hands-on software development/programming experience and computerised system validation experience in a GxP environment.
  • An analytical, proactive approach, strong documentation and planning skills, and the ability to work independently and across teams.
  • Excellent written and spoken English; Dutch is a plus.
  • Must reside within 60 km of Leiden.
  • Candidates who do not have a valid work permit for the Netherlands will not be considered.

Preference: Laboratory experience, familiarity with systems such as Empower, LIMS or TrackWise, TECAN robotics, GAMP5, 21 CFR Part 11 or Lean/Six Sigma. Ready to put your technical and investigative skills to work? Lisette Spoelder Want to know more about the possibilities? Contact us. ...

Skills

21 CFR Part 11LIMcomputerized system validationCAPAData IntegritySoftware DevelopmentProgrammingAutomationQuality assuranceGxP environmentEmpowerTrackwise

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