Key Skills

Job Description

🚀 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.

Core Responsibilities

Lead the implementation, lifecycle management, administration, maintenance, and troubleshooting of laboratory computerized systems, ensuring GMP and 21 CFR Part 11 compliance. Investigate non-conformances, determine root causes, implement CAPAs, and support audits while collaborating across Quality, QC, IT, Engineering, and global teams.

Requirements

A bachelor's degree in Life Sciences, Computer Science, or a related discipline and experience in a GMP-regulated pharmaceutical environment are required. Candidates should have strong knowledge of computerized systems, data integrity, and CSV, hands-on software, automation, programming, or laboratory systems experience, and proven deviation and CAPA investigation experience; English fluency is required, while Dutch is an advantage.