Sr Quality Engineer - Cleaning Validation

Sr Engineer QA Cleaning Validation

Learn more about the general tasks related to this opportunity below, as well as required skills.

Location: Geel, Belgium

Innovative Medicine Supply Chain Geel serves as the center of excellence for the development and manufacturing of SM-APIs and DP Intermediates used in treatments that improve the health and lifestyle of people worldwide. Innovative Medicine Synthetics Quality (IMSQ) supports the Geel site in its mission as a Launch & Grow site, ensuring quality oversight and final release of APIs and DP Intermediates to guarantee reliable, compliant supplies.

As Sr Quality Engineer, you will act as the Subject Matter Expert for cleaning validation, providing quality oversight across the site's cleaning validation program.

Your responsibilities:

• Ensure all cleaning validation related regulatory and procedural requirements are fulfilled
• Provide strategic input to the compliance improvement plan for cleaning validation
• Deliver QA oversight on cleaning validation actions within the System Based Compliance action plan
• Review and approve cleaning validation documents - SOPs, risk analyses, validation protocols & reports, tests, trend reports, changes, and deviations - to maintain compliance with regulations, guidelines, and company policies and standards
• Collaborate with MSAT, Operations, and other teams to introduce new cleaning validation concepts and methodologies
• Advise and support cleaning validation activities, safeguarding cGMP aspects in new projects, and contribute as a member of multi-functional teams on cross-departmental objectives

What you bring:

• Master's degree in a scientific discipline, or equivalent experience
• 10 years of experience in the pharmaceutical or chemical industry
• Strong knowledge of cGMP/cleaning validation compliance (EU cGMP, ICH Q7, 21 CFR Part 211) and quality risk management xlxgzvr (ICH Q9)
• Hands-on experience with cleaning validation
• Strong sense of ownership and a quality-driven mindset, with a track record of delivering on committed timelines
• Sharp analytical thinking and the flexibility to work under time pressure
• Sound judgment for risk-based decision-making, with an understanding of the business implications of quality positions and decisions
• A proactive, accurate way of working across organizational boundaries, as part of One Team
• Fluency in English and Dutch, both written and verbal, with strong cross-functional communication skills