NC Automation Specialist | Quality Control Laboratories | GMP & Data Integrity
Are you passionate about laboratory automation, computerized systems, and quality compliance in a GMP-regulated environment? We are looking for an experienced
NC Automation Specialist
to support QC laboratories and serve as the Subject Matter Expert for automation, data integrity, computerized systems, and laboratory robotics. In this role, you will play a critical part in ensuring product quality and regulatory compliance while driving continuous improvement and LEAN initiatives across laboratory operations. What you'll be doing:
Lead the implementation and lifecycle management of laboratory computerized systems, from standalone analytical instruments to complex platforms integrated with LIMS. Act as the automation and data integrity SME, ensuring systems comply with GMP requirements and 21 CFR Part 11 standards. Own and maintain system administration, technical installation, maintenance, backup, and disaster recovery procedures. Troubleshoot and resolve computerized system issues while supporting day-to-day laboratory operations. Lead investigations into non-conformances (NCs), identifying root causes and implementing effective corrective and preventive actions (CAPAs). Apply structured root cause analysis methodologies such as Fishbone, 5 Whys, KT Analysis, and operator interviews. Support audits and regulatory inspections as a Subject Matter Expert. Collaborate with Quality, QC, IT, Engineering, and Global teams to deliver compliant and efficient laboratory solutions. What we're looking for:
Bachelor's degree in Life Sciences, Computer Science, or a related discipline. Experience within a GMP-regulated pharmaceutical environment. Strong knowledge of computerized systems, data integrity, and system validation (CSV). Hands-on experience with software development, automation, programming, or laboratory systems. Proven experience investigating deviations, non-conformances, and CAPAs. Excellent analytical, problem-solving, and stakeholder management skills. Fluent in English. Dutch is considered an advantage. Nice to have:
Experience with Empower, SoftMax Pro, SDMS, Deskman, LIMS, 32Karat, or TrackWise. Experience with laboratory robotics and TECAN systems. Knowledge of GAMP5, 21 CFR Part 11, and Lean/Six Sigma methodologies. Why this opportunity?
This position offers a unique combination of
automation, quality, data integrity, compliance, and continuous improvement
within a highly regulated pharmaceutical environment. You'll have the opportunity to influence laboratory digitalization initiatives while ensuring the highest standards of product quality and regulatory compliance. Interested or know someone who might be a great fit? Feel free to reach out for a confidential discussion.
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Automation Specialist in Leiden werkgever: DPS Group Global
DPS Group Global biedt een stimulerende werkomgeving in Sassenheim, waar je als Maintenance Engineer de kans krijgt om bij te dragen aan de groei van een innovatieve biopharma-faciliteit. Met een sterke focus op teamwork en professionele ontwikkeling, biedt het bedrijf uitstekende mogelijkheden voor persoonlijke groei en een cultuur die samenwerking en creativiteit bevordert. Daarnaast profiteer je van competitieve voordelen en een dynamische werkplek die gericht is op het verbeteren van de betrouwbaarheid van apparatuur en processen.
