Continuous Improvement Engineer - Production

Main responsibilities

In your position as CI Engineer, you will focus on technical aspects and quality aspects of improvement.

In Technical Aspects:

• Experience with and knowledge of equipment, principles and practices of preparative chromatography, column packing, centrifugation, and ultrafiltration/diafiltration (UF/DF), Aseptic Filling lines and Lyophilization in a pharmaceutical environment.
• Experience with manufacturing equipment & auxiliary equipment such as tanks, process instrumentation, autoclaves, washers, clean utilities and CIP/SIP systems.
• Experience with process control and automation, implementing logics on PLC and SCADA is highly preferred.
• Support continuous improvement teams as per requirement.
• Preparation of Qualification/Validation documentation regarding PQ/PPQ and Process Verification, basic knowledge, commissioning FAT/SAT and qualification IOQ and PQ.
• Troubleshooting, root cause analysis, FMEAs, and basic Project Management.

In Quality Aspects:

• Broad understanding of (c)GMP.
• Handling change controls and CAPAs in an eQMS/eDMS.
• Understanding relevant International guidelines ISPE/ICH/FDA.

Your profile

• Bachelor/ Master degree, including relevant experience, in relevant study such as Pharmaceutical Engineering, Chemical Technology, Mechanical Engineering, (Bio) Process Technology or Biochemistry.
• Thorough GMP and validation knowledge and experience.
• Lean Six Sigma (green belt, black belt) is a nice to have.
• Strong quality awareness and familiar working with deliverables and deadlines.
• Self-starter and team player
• Experience as project team member.
• Fluent in English and Dutch – oral & writing – is a necessity; including technical reports.

What do we offer?

• Full-time employment (40h) with flexible working hours in consultation. Working part-time can be discussed.
• 8.33% end-of-year bonus and 8.33% holiday allowance.
• A personal training budget of €2,100 every three years to foster professional growth and development.
• Contribution to travel expenses from the first kilometer.
• Excellent accessibility by public transport and private parking available.
• A pension plan with Zorg & Welzijn, providing security for your future.
• A dynamic, safe, and challenging working environment with ample opportunities to grow, innovate, and learn, all while making a meaningful impact on the health of millions.