Job Role: Automation Specialist - QC Laboratories
About the Role: We are seeking an experienced Automation Specialist to support QC laboratories in a pharmaceutical environment. This role focuses on laboratory automation, computerized systems, data integrity and GMP compliance. You will act as a Subject Matter Expert (SME) for laboratory systems, supporting technical implementations, troubleshooting and system maintenance. You will also lead non-conformance investigations, perform root cause analysis and implement corrective and preventive actions (CAPA). Key Responsibilities:
Lead the technical implementation of laboratory systems, from standalone analytical instruments to complex platforms integrated with LIMS. Create and maintain technical installation, administration and maintenance procedures. Ensure data integrity, including backup strategies and disaster recovery planning. Provide technical support and troubleshoot computerized systems and laboratory automation issues. Ensure laboratory equipment and computerized systems comply with GMP and 21 CFR Part 11 requirements. Collaborate with cross-functional and global teams on laboratory systems projects. Lead investigations into non-conformances related to QC testing, raw materials, in-process materials, drug substance and drug product. Perform root cause analysis using tools such as 5 Whys, Fishbone diagrams and operator interviews. Define, coordinate and implement corrections, CAPAs and effectiveness checks. Act as a Subject Matter Expert during internal audits and external inspections. Support continuous improvement and LEAN initiatives across laboratory processes. Key Competencies:
Strong analytical thinking and technical problem-solving skills. Excellent documentation skills, with attention to data integrity and regulatory compliance. Proactive and independent, with the ability to take initiative and translate business needs into technical solutions. Strong communication and collaboration skills across different departments and organizational levels. Ability to manage priorities and support day-to-day laboratory operations. Excellent written and spoken English; Dutch is an advantage. Requirements:
Bachelor's degree (HBO) in Life Sciences, Computer Science or a related field, or equivalent relevant experience. Minimum of 2 years of pharmaceutical industry experience involving GMP and automation responsibilities. Hands-on experience with software development and programming. Experience with Computer System Validation (CSV) in a GxP environment. Understanding of GMP regulations, quality control procedures and relevant FDA and EMA guidelines. Experience with laboratory systems such as Empower, SoftMax Pro, SDMS, LIMS, 32Karat or TrackWise is an advantage. Knowledge of laboratory robotics, particularly TECAN, is desirable. Familiarity with GAMP 5, 21 CFR Part 11 and Lean/Six Sigma is a plus. Practical Info:
Location: Leiden, The Netherlands Duration: 1 year Work Model: Hybrid Employment Type: Full-time Start Date: ASAP
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NL - Specialist 3, Validation in Leiden werkgever: Panda International
Als werkgever in Breda biedt ons bedrijf een dynamische en ondersteunende werkomgeving waar medewerkers de kans krijgen om hun vaardigheden in supply chain planning te ontwikkelen en te verbeteren. We stimuleren een cultuur van samenwerking en continue verbetering, met mogelijkheden voor persoonlijke groei en professionele ontwikkeling. Met een focus op standaardisatie en procesautomatisering, zijn we toegewijd aan het creëren van een efficiënte en stabiele operatie die bijdraagt aan de gezondheid van patiënten in bijna 100 markten.
