Senior Cleaning Validation Engineer — Impactful QA in Pharma

MindCapture; Belgique; À distance; EUR 90 000 - 130 000; Plein temps

Avantages offerts par ce poste

Meal vouchers

Eco vouchers

Health insurance

Group insurance

Net expense allowance

Company car with charging or fuel card

Résumé du poste

MindCapture is seeking a Sr Quality Engineer specialized in cleaning validation to join our consultancy team in Belgium. You will review validation documentation, provide strategic input for compliance improvements, and collaborate with multidisciplinary stakeholders to uphold cGMP requirements on high-tech diagnostic systems.

The role emphasizes building robust validation concepts, quality risk management, and cross-functional collaboration within a consulting framework for healthcare systems.

Qualifications

• Master degree in a scientific discipline or equivalent professional experience.
• At least 10 years of experience in pharmaceutical or chemical industries.
• Demonstrated experience with cleaning validation in a regulated environment.
• Strong knowledge of cGMP requirements, European GMP expectations, ICH Q7 and applicable regulations.
• Strong understanding of quality risk management (ICH Q9).
• Ability to make sound risk-based decisions while considering business impact.
• Strong analytical capabilities under time pressure.
• Proactive, accountable work style with commitment to timelines.
• Fluent written and spoken English and Dutch with stakeholder communication skills.

Responsabilités

• Ensure cleaning validation compliance with regulatory and procedural requirements.
• Provide quality assurance oversight for cleaning validation actions within broader compliance programs.
• Contribute to compliance strategy and risk-based improvement plans.
• Review and approve procedures, risk analyses, validation protocols, reports and deviations.
• Ensure alignment with applicable regulations, guidelines and quality standards.
• Collaborate to develop new cleaning validation concepts and methodologies.
• Advise stakeholders on cleaning validation activities within new projects while safeguarding cGMP.
• Participate in cross-functional teams to achieve quality and operational goals.

Connaissances

Analytical thinking

Quality mindset

Decision making

Ownership

Collaboration

English language

Dutch language

Regulatory compliance

cGMP knowledge

ICH Q9/Q7 knowledge

Formation

Master degree in a scientific discipline

Description du poste

MindCapture is seeking a Sr Quality Engineer specialized in cleaning validation to join our consultancy team in Belgium. You will review validation documentation, provide strategic input for compliance improvements, and collaborate with multidisciplinary stakeholders to uphold cGMP requirements on high-tech diagnostic systems.

The role emphasizes building robust validation concepts, quality risk management, and cross-functional collaboration within a consulting framework for healthcare systems.