Automation Specialist Pharma (CSV-QA)

Talentmark
Leiden, Netherlands
11 days ago
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Role details

Contract type
Temporary contract
Employment type
Full-time (> 32 hours)
Experience level
Experienced
Experience required
2 years minimum
Working hours
Regular working hours
Languages
Dutch, English

Tech stack

Computer Programming Data Integrity Laboratory Information Management Systems Software Engineering System Testing Information Technology Trackwise GXP

Job description

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.

Requirements

  • 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? Apply now and help build reliable, compliant laboratory operations.

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