Senior QA Engineer: Cleaning Validation Expert

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

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.