Automation Specialist Pharma (CSV-QA)

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