Sr Engineer QA Cleaning Validation
Location: Geel, Belgium
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 (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