Senior Quality Engineer – Cleaning Validation (cGMP)

MindCapture; Belgique; Sur place; EUR 90 000 - 120 000; 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 seeks a Senior Quality Engineer for Cleaning Validation to be placed on site with a healthcare client in Belgium. You will act as a subject matter expert, reviewing validation documentation, shaping compliance improvements, and safeguarding cGMP.

The role requires a Master’s degree, 10+ years in pharma/chemical, and fluency in English and Dutch. You’ll collaborate across disciplines to implement robust validation concepts and drive quality and patient care outcomes.

Qualifications

• Master degree in a scientific discipline or equivalent professional experience.
• At least 10 years of experience in pharma or chemical industry.
• Cleaning validation experience in a regulated environment.
• Strong knowledge of cGMP, European GMP, ICH Q7 and related regulations.
• Quality risk management knowledge (ICH Q9).
• Ability to make risk-based decisions with business impact.
• Strong analytical thinking under time pressure.
• Proactive ownership with high quality mindset and timelines.
• Collaborative across organizational boundaries and multidisciplinary teams.
• Fluent written and spoken English and Dutch with strong stakeholder communication skills.

Responsabilités

• Cleaning validation compliance: Ensure regulatory and procedural requirements for cleaning validation are fulfilled.
• Quality oversight for cleaning validation actions within broader compliance improvements.
• Compliance strategy: Provide input to plans strengthening cleaning validation compliance.
• Document approval: Review and approve procedures, risk analyses, validation protocols, reports, tests, trend reports, changes and deviations.
• Regulatory alignment: Ensure activities comply with regulations, guidelines and quality standards.
• Methodology development: Collaborate to introduce new cleaning validation concepts and methodologies.
• Project support: Advise stakeholders on cleaning validation activities within cGMP requirements on new projects.
• Cross functional collaboration: Participate in multidisciplinary teams to achieve objectives.

Connaissances

Quality mindset

Analytical thinking

Decision making

Ownership

Collaboration

English

Dutch

Formation

Master degree in a scientific discipline

Description du poste

MindCapture seeks a Senior Quality Engineer for Cleaning Validation to be placed on site with a healthcare client in Belgium. You will act as a subject matter expert, reviewing validation documentation, shaping compliance improvements, and safeguarding cGMP.

The role requires a Master’s degree, 10+ years in pharma/chemical, and fluency in English and Dutch. You’ll collaborate across disciplines to implement robust validation concepts and drive quality and patient care outcomes.