Automation Specialist

Work location:Leiden, the Netherlands (Hybrid) 
Pay rate: €38,56/h - CoE 
Contract duration: 12 months with a possibility of extension  
Client: A global healthcare company specialising in medical devices, pharmaceutical products and innovative healthcare solutions. 

About the role:  

We are seeking an experienced Automation Specialist with a strong affinity for analysis methodology and computerized systems to support our QC laboratories. You will act as the Subject Matter Expert for automation topics - including data integrity, introduction and maintenance of computerized systems and laboratory robotics - and help ensure GMP compliance while supporting LEAN initiatives across the team and process.  

The primary responsibility of this role is to perform, document, and manage investigations regarding non-conformances. It focusses on the identification of root causes, defining and implementing corrections, corrective actions, and preventive measures in accordance with Good Manufacturing Practices (GMP) and regulatory requirements. The NC Automation specialist has a strong background in quality control, quality assurance, or a related field within the pharmaceutical industry and the ability to work collaboratively across departments to ensure product quality and compliance. 

Responsibilities 

• Lead technical implementation of new laboratory systems in collaboration with cross-functional teams. Systems range from standalone analytical instruments to complex global platforms interfacing with LIMS.  
• Create and maintain administrator, technical installation, and maintenance procedures.  
• Own data integrity practices, including backup strategies and (disaster) recovery planning. 
• Provide timely support and troubleshooting for computerized system issues.  
• Ensure equipment implementations meet 21 CFR Part 11 compliance requirements.  
• Participate in lab systems initiatives and projects in cooperation with the global organization and aligned with business needs.  
• Support and troubleshoot day-to-day challenges as part of the support team.  
• Lead and conduct thorough investigations of non-conformances related to testing (raw materials, in-process materials, Drug substance, Drug product) and ancillary processes.  
• Define, coordinate and/or implement appropriate correction/corrective & preventive actions and effectiveness checks associated with Non-Conformance records. 
• Perform root cause analysis using appropriate tools (e.g., Operator interview, Fishbone, 5 Whys, KT analysis) and ensure comprehensive corrective and preventive actions (CAPA) are defined and implemented.  
• Act as SME and participate in (the preparations of) internal audits and external Inspections, as deemed applicable. 

Expectations: 

• Bachelor’s degree (HBO) in Life Sciences, Computer Science, or equivalent experience in a similar role.  
• Solid understanding of relevant local and global procedures and basic understanding of GMP regulations, FDA and EMA guidelines, as well as industry best practices for quality control and compliance.  
• Minimum 2 years’ experience in the pharmaceutical industry with GMP and automation responsibilities. 
• Hands-on background in software development and programming. Laboratory experience is a plus.  
• Experience with (Computer) System Validation in a GxP environment.  
• Strong analytical thinking, technical problem solving, and planning/prioritization skills.  
• Proven ability to engage and build productive relationships across all organizational levels. 
• Excellent written and oral English; Dutch is desirable.  
• Proactive, able to work independently, take initiative, and produce protocols, reports, and procedures.  

Desirable (nice-to-have)  

• Experience with any of: Empower, Softmax Pro, SDMS, Deskman, LIMS, 32Karat, Trackwise systems.  
• Experience with robotics or programming (in particular TECAN).  
• Familiarity with GAMP5 and 21 CFR Part 11.  
• Lean/Six Sigma experience