Senior QA Engineer – Cleaning Validation

Johnson & Johnson; Geel; Sur place; EUR 69 000 - 124 000; Plein temps

Résumé du poste

Johnson & Johnson Innovative Medicine seeks a Senior Engineer (QA Cleaning Validation) to lead quality oversight for cleaning validation at the Geel site. This on-site role partners with MSAT and operations to uphold regulatory requirements and drive improvements.

The candidate should have 5–10 years in pharma/chemical industries, strong knowledge of cGMP and cleaning validation, and excellent English communication skills, with Dutch as a bonus.

Qualifications

• Master's degree or equivalent experience.
• Strong experience with cleaning validation.
• 5-10 years of experience in the pharmaceutical (or chemical) industry.
• Knowledge of cGMP/ cleaning validation compliance (EU cGMP, ICH Q7, 21 CFR Parts 211, ...) and quality risk management approaches (ICH Q9).
• Strong ownership and quality attitude. Able to deliver on committed timelines.
• Fluent in English; Dutch is a bonus.

Responsabilités

• To assure that all cleaning validation related regulatory and procedural requirements are fulfilled.
• Provide strategic input to the compliance improvement plan for cleaning validation at Johnson & Johnson.
• Ensure QA oversight on the cleaning validation actions in the System Based Compliance action plan.
• Review and approve cleaning validation documents such as SOPs, risks analyses, validation protocols & reports, tests, trend reports, changes, deviations etc. to maintain compliance.
• Cooperate with MSAT, operations and other teams for the introduction of new cleaning validation concepts and methodologies.
• To give advice and support for the preparation of cleaning validation related activities and guard the cGMP aspects in new projects. Be a member of multi-functional teams to realize cross-departmental objectives.

Connaissances

Cleaning validation

Quality oversight

Regulatory compliance

cGMP

Formation

Master's degree

Outils

SOPs

Validation protocols

Description du poste

Imagine your next project as a Senior Engineer (QA Cleaning Validation), working at the forefront of cutting edge work and technology with one of the leading Pharmaceutical companies in the world!

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 Launch & Grow site and is responsible for the quality oversight and final release of APIs and DP Intermediates guaranteeing reliable supplies in compliance with applicable regulations.

roles and responsibilities

As Sr Quality Engineer, you act as Subject Matter Expert ensuring quality oversight for cleaning validation. This will involve:

• To assure that all cleaning validation related regulatory and procedural requirements are fulfilled.
• Provide strategic input to the compliance improvement plan for cleaning validation at J&J.
• Ensure QA oversight on the cleaning validation actions in the System Based Compliance action plan.
• Review and approve cleaning validation documents such as SOPs, risks analyses, validation protocols & reports, tests, trend reports, changes, deviations etc...) in order to maintain compliance to regulations, guidelines, J&J policies and standards.
• Cooperate with MSAT, operations and other teams for the introduction of new cleaning validation concepts and methodologies.
• To give advice and support for the preparation of cleaning validation related activities and guard the cGMP aspects in new projects. Be a member of multi-functional teams to realize cross-departmental objectives.

how to succeed

• Master scientific degree or equivalent experience.
• Strong experience with cleaning validation.
• 5- 10 years of experience in the pharmaceutical (or chemical) industry.
• Knowledge of cGMP/ cleaning validation compliance (EU cGMP, ICH Q7, 21 CFR Parts 211, ...) and quality risk management approaches (ICH Q9)
• Strong ownership and quality attitude. You are able to deliver on committed timelines.
• Strong analytical thinking skills and able to work in a flexible way under time pressure.
• Ability to make risk-based decisions. Understands the business implications regarding quality positions and decisions.
• You work accurately and proactively across organizational boundaries as One Team.
• Fluent in verbal and written communication in English and are able to connect with diverse partners.
• Dutch is a bonus.

This role offers a very competitive hourly rate. This contract will run until the end of the year initially (31st December 2026). This is an on-site position.

you are welcome here

Johnson & Johnson Innovative Medicine is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson Innovative Medicine

Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow.

Our diverse portfolio spans multiple therapeutic areas - Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina.

We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means 'You Belong'.