QA Qualification Engineer

☞ Johnson & Johnson

Visualizza: 140

Giorno di aggiornamento: 25-11-2025

Località: Geel Antwerp

Categoria: Alta tecnologia IT - Software

Industria: Hospitals Health Care

Tipo di lavoro: Full-time

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Contenuto del lavoro

Description:

Within Janssen Supply Chain, a member of Johnson & Johnson’s Family of Companies, we are recruiting a Senior Quality Engineer (M/F/X). You will be a member of our quality engineering team ensuring quality oversight for production equipment related to manufacturing of Small Molecule Active Pharmaceutical Ingredients (SM-API) and Drug Product Intermediates at the Janssen Supply Chain site in Geel, Belgium. You will be part of an enthusiastic team that has a strong quality focus on technology, qualification, automation, and continuous improvement. Employees are very valuable to our organization and development is a daily responsibility. Through on the job training, e-learning, implementation of various projects and programs we ensure personal growth by focusing on your talents. We offer you a contract of indefinite duration with an attractive salary package including extra-legal benefits such as meal vouchers, additional pension plan and hospitalization insurance.

Janssen Supply Chain Geel serves as Centre 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. Janssen Supply Chain Quality (JSCQ) supports the Geel site in its mission as Launch & Grow site and is responsible for the quality oversight and final release of SM-APIs and DP Intermediates guaranteeing reliable supplies in compliance with applicable regulations.

As Senior Quality Engineer, you act as Subject Matter Expert ensuring quality oversight for production equipment.

Your main responsibilities:

  • To assure that all Equipment Qualification related regulatory requirements are fulfilled during the complete life cycle (concept, project, operational and retirement phase).
  • Review and approve Qualification documents such as SOPs, user requirements, risks analysis’s, Qualification Plans, tests, changes, deviations etc…) in order to maintain compliance to regulations, guidelines, J&J policies and standards.
  • Maintain a current knowledge of international laws, guidelines and new evolutions related to Qualification through courses, conferences, seminars, internal and external benchmarking and literature studies. Implement this knowledge to maintain and improve Equipment Qualification at J&J.
  • Prepare for and be spokesperson in audits and inspections.
  • Perform and follow up on internal and external audits to accomplish regulatory compliance.
  • Cooperate with engineering, operations and other teams for the introduction of new systems and processes.
  • To give advice and support for the preparation of Qualification related activities and guard the cGMP aspects in new projects. Be a member of multi-functional teams to realize cross-departmental objectives.
  • Ensuring that Innovation projects are designed and implemented within the GMP Quality framework, including compliant, timely and properly handling of quality records such as Change Controls, Investigations and CAPAs.

Qualifications:

  • Master scientific degree or equivalent experience.
  • 4 - 6 years’ experience in pharmaceutical or chemical industry.
  • Knowledge of cGMP/Qualification compliance (21 CFR Parts 211; EU Directive 2003/94/EC and annex 15; ICH Q7,…)
  • Experience with Equipment Qualification.
  • Strong ownership and quality attitude. You are able to deliver on commitment 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 Dutch and are able to connect with diverse partners.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
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Scadenza: 09-01-2026

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