Johnson & Johnson

About the Company

At Johnson & Johnson, we believe health is everything. As a focused healthcare company, with expertise in Innovative Medicine and MedTech, we're empowered to tackle the world's toughest health challenges, innovate through science and technology, and transform patient care.

All of this is possible because of our people. We're passionate innovators who put people first, and through our purpose-driven culture and talented workforce, we are stronger than ever.

Learn more at https://www.jnj.com. Community Guidelines: http://www.jnj.com/social-media-community-guidelines

Listed Jobs

Company Name

Johnson & Johnson

Job Title

QA Commissioning and Qualification Engineer

Job Description

Job title: QA Commissioning and Qualification Engineer – CAR‑T Role Summary: Responsible for reviewing and approving qualification and requalification activities of facilities, utilities and process equipment for CAR‑T manufacturing, ensuring cGMP compliance and data integrity. Expectations: - Maintain and defend qualification status of critical production assets. - Evaluate and resolve deviations with impact on quality or compliance. - Ensure corrective/preventive actions are defined, implemented, and documented. - Communicate effectively with manufacturing, MAM, E&PS, and quality teams. Key Responsibilities: - Review and approve qualification documents (change controls, protocols, SOPs, URS, IA, QSR, reports). - Verify calibration rationales, master forms, calibration records, and master data setup. - Monitor system audit trails, user access reviews, and data‑integrity deliverables. - Coordinate with manufacturing on change control approval. - Manage compliance of equipment and facilities through certification and re‑certification cycles. - Participate in process improvement/optimization projects, ensuring quality and regulatory alignment. - Maintain up‑to‑date knowledge of FDA/EU guidelines and international regulations for cell‑therapy manufacturing. Required Skills: - Strong knowledge of cGMP, FDA/EU guidance for cellular therapies, and quality system documentation. - Proficiency in computerized system parameter configuration and data management. - Ability to analyze risks, investigate deviations, and develop robust CAPA plans. - Excellent written and oral communication in Dutch and English. - Team‑oriented, collaborative mindset, capable of working across departments in dynamic environments. - Analytical thinking, strong attention to detail, and proactive problem‑solving. Required Education & Certifications: - Master’s degree in engineering (chemical/analytical), pharmaceutical sciences, or related field. - Prior experience in pharmaceutical QA/QC or GMP‑regulated manufacturing, preferably with cell‑therapy products. - Certifications such as ISO 17025, GMP, or QMS not mandatory but preferred.

Ghent, Belgium

Hybrid

10-03-2026