Expert Quality Engineering

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Supply Chain Engineering

Job Sub Function:
Quality Engineering

Job Category:
Scientific/Technology

All Job Posting Locations:
Gent, East Flanders, Belgium

Job Description:

About Innovative Medicine  

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements.

Visionaries like you work on teams that save lives by developing the medicines of tomorrow. 

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. 

Learn more at https://www.jnj.com/innovative-medicine

In this role, you are reporting in the J&J QA CAR-T organization and work closely with your peers from Material Science and Technology, Operations and Quality Control.

We are searching for the best talent for a Expert Quality Engineering to be in Gent.

The successful candidate will be responsible for ensuring that the manufacturing processes meet quality standards and regulatory requirements.

This role involves working closely with cross-functional teams, including Technical Operations, Manufacturing, Vein-to-Vein department and Regulatory affairs, to drive continuous improvement and support the development and commercialization of CAR T-cell therapies.

You will be responsible for:


* Investigation Support: Provide technical, quality, and compliance expertise to support in-depth investigations related to deviations to ensure timely resolution.


* Deviation Management: Ensure that deviations are promptly and thoroughly investigated, with particular attention to those that may affect patient safety or product supply.

Escalate issues that could have significant impacts on quality.


* CAPA Management: Ensure that appropriate corrective and preventive actions (CAPAs) are identified and implemented in response to investigations, especially those with potential impacts on product quality and patient safety.


* Quality Oversight Participation: Contribute to the quality oversight programs by providing documented QA approval for GMP documentation and actively participating in quality review meetings to support operational activities.


* Inspection and Audit Support: Assist in the preparation, execution, and follow-up of internal and external inspections and audits to ensure compliance with Good Manufacturing Practices (GMP) and other regulatory requirements.



* C...