Process Investigator

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:
Manufacturing 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 

WE for a Process Investigator function in the Manufacturing Science & Technology (MSAT) CAR-T EMEA organization, located in Ghent Belgium.

The MSAT CAR-T EMEA organization is an organization which provides and supports a high degree of assurance that specific processes will consistently produce and meets its pre-determined specifications by deploying process validation, process system engineering, data architecture and continuous process verification and process investigation.

The Process Investigator is the role for providing quality investigation insights over the manufacturing of a personalized cell therapy to support both clinical and commercial requirements in a sterile GxP environment.

This includes assessing process information, reviewing in-the-field manufacturing investigations, follow up on various departmental post-implementation optimizations and tracking of quality metrics while ensuring high quality and compliant product supply.

The Process Investigator will be part of this MSAT team and is responsible for:


* Own the investigation process and methodologies, create awareness and educate the organization on the importance of and how to adequately and efficiently handle and document quality non-conformances.


* Responsible for handling multiple department manufacturing investigations as appropriate to meet critical release windows (the highest priority being safe, compliant and timely product release for the patient).


* Build solid and long-lasting connections with different stakeholders in order to ensure smooth alignment and handling of complex investigations, while acting as the shopfloor single point of contact.


* Collaborate with functional departments to provide guidance and determine resolution for manufacturing issues/deviations/no...