Sr Quality Engineer - Cleaning Validation

Panda International; Geel; Sur place; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Innovative Medicine Supply Chain Geel is hiring a Sr Quality Engineer to lead cleaning validation oversight for the Geel site. You will ensure regulatory and procedural requirements are fulfilled and provide strategic input to continuous improvement in cleaning validation programs.

The role requires a Master’s in a scientific field with 10 years in pharma/chemical industries, deep cGMP knowledge, hands-on validation experience, and strong English-Dutch communication for cross-functional teams.

Qualifications

• Master's degree in a scientific discipline or equivalent experience.
• 10 years of experience in the pharmaceutical or chemical industry.
• Strong knowledge of EU cGMP, ICH Q7, 21 CFR Part 211 and ICH Q9.
• Hands-on experience with cleaning validation.
• Ownership mindset and a quality-driven approach to deadlines.
• Sharp analytical thinking and ability to work under time pressure.
• Risk-based decision making with understanding of business impact.
• Proactive cross-functional collaboration across teams and boundaries.

Responsabilités

• Ensure regulatory and procedural requirements for cleaning validation are fulfilled.
• Provide 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.

Connaissances

Cleaning validation

Regulatory compliance

Quality risk management

Analytical thinking

Cross-functional collaboration

Time management

Fluent English and Dutch

Formation

Master's degree in a scientific discipline

Description du poste

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 (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