Automation Specialist Pharma (CSV-QA)

Talentmark; Leiden; Hybrid; EUR 60,000 - 85,000; Full time

Job summary

Talentmark is seeking an Automation Specialist Pharma (CSV-QA) in Leiden. The role blends hands-on automation work with investigations to ensure data integrity and GMP compliance in QC labs.

You will lead CAPAs, validate systems, and collaborate across teams on automation projects to support GMP and 21 CFR Part 11. English Fluency required; Dutch a plus; 60 km radius living requirement applies.

Qualifications

• Bachelor’s degree HBO in Life Sciences, CS or equivalent experience.
• 2+ years pharma GMP and automation experience.
• Hands-on software development and computerized system validation in GxP.
• Excellent written and spoken English; Dutch is a plus.

Responsibilities

• Lead non-conformance investigations and CAPA.
• Maintain and troubleshoot laboratory systems from instruments to LIMS.
• Safeguard data integrity and GMP/21 CFR Part 11 compliance.
• Collaborate on automation projects, continuous improvement and audits.

Skills

Analytical mindset

Documentation skills

Planning skills

Team collaboration

Education

Bachelor’s degree HBO in Life Sciences or CS

Tools

Empower

LIMS

TrackWise

TECAN robotics

Job description

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.