Automation Specialist

Talentmark; Leiden; On-site; EUR 60,000 - 90,000; Full time

Job summary

Talentmark in Leiden seeks an automation specialist for pharmaceutical QC labs. You will combine hands-on programming with non-conformance investigations to strengthen data integrity and ensure GMP and 21 CFR Part 11 compliance.

You will maintain laboratory systems, from analytical instruments to LIMS-connected platforms, document technical work, and collaborate on automation projects and audits across teams.

Qualifications

• Bachelor's degree or higher in Life Sciences or related field with GMP exposure.
• Experience with GxP environments and data integrity concepts is required.
• Experience in non-conformance investigations and CAPA processes is a plus.

Responsibilities

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

Skills

Automation programming

Data integrity

Analytical mindset

Education

BSc HBO Life Sciences

Tools

Empower

LIMS

TrackWise

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.

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.