Sr Quality Engineer Cleaning Validation

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

Jobs / Sr Quality Engineer Cleaning Validation

At MindCapture you are not just starting a new role. You are joining a community that invests in your development and gives you the opportunity to grow in a meaningful technical career within healthcare.

You can count on:

• A competitive salary with a full benefits package including meal vouchers, eco vouchers, health insurance, group insurance, net expense allowance and a company car with charging or fuel card
• Personal growth support with tailored training and clear career development
• A stable environment where your technical skills directly contribute to improved patient care
• The chance to work with high tech diagnostic systems at top tier healthcare institutions
• A warm and collaborative culture focused on trust, ownership and long term impact

You will act as a subject matter expert for cleaning validation, ensuring compliance with applicable pharmaceutical regulations, quality standards and internal procedures. You will review validation documentation, provide strategic input to compliance improvements and collaborate with multidisciplinary stakeholders to introduce appropriate validation concepts while safeguarding cGMP requirements.

Key responsibilities

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

Required competences & skills

• Education: Master degree in a scientific discipline or equivalent professional experience.
• Industry experience: At least 10 years of experience within the pharmaceutical or chemical industry.
• Cleaning validation: Demonstrated experience with cleaning validation in a regulated environment.
• Regulatory knowledge: Strong knowledge of cGMP requirements, European GMP expectations, ICH Q7 and applicable pharmaceutical regulations.
• Quality risk management: Strong understanding of quality risk management principles including ICH Q9.
• Decision making: Ability to make sound risk based decisions while understanding their broader business implications.
• Analytical thinking: Strong analytical capabilities with the flexibility to perform effectively under time pressure.
• Ownership: Proactive and accurate working style with a strong quality mindset and commitment to agreed timelines.
• Collaboration: Ability to work effectively across organisational boundaries and within multidisciplinary teams.
• Languages: Fluent written and spoken English and Dutch with strong stakeholder communication skills.
  

Quality & Compliance Geel Senior At MindCapture as consultant

About this application

This opportunity is offered through MindCapture as a consultancy role with strong day to day ownership. You will be placed on site with our client.

MindCapture supports you throughout your assignment with clear onboarding, regular follow up and access to learning opportunities. You will have a dedicated point of contact, transparent communication and support to help you deliver impact in a structured way.

Job Contact – Talent & Business Team

Our Talent & Business Managers combine a deep understanding of our clients' needs with a sharp eye for talent. Their focus is on creating meaningful and sustainable matches, always keeping both the role and the candidate in mind.

When a potential match is identified, one of our T&B colleagues may reach out to answer your questions, share additional context about the role and discuss possible next steps together, with clarity and transparency throughout the process.