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:
Quality Engineering

Job Category:
Scientific/Technology

All Job Posting Locations:
Beerse, Antwerp, Belgium, Gent, East Flanders, Belgium

Job Description:

We are searching for the best talent for Process Investigator to be in Gent and Beerse, Belgium.

Johnson & Johnson Innovative Medicine is recruiting for Process Investigator in the Manufacturing Science & Technology CAR-T EMEA, located in Ghent & Beerse 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 production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP 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.

You will be 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.


* Build solid and long-lasting connections with different stakeholders at Beerse Campus in order to ensure smooth alignment and handling of complex investigations, while acting as the shopfloor single point of contact for particulate matter investigations :
+ Be the SPOC for QC particulate matter review regarding Ghent manufacturing site
+ Willingness to be bi-weekly on the Ghent sites if needed


* Collaborate with manufacturing teams to provide guidance and determine resolution for manufacturing issues/deviations/non-conformances.


* Ensure accurate and timely reviews of manufacturing investigations, CAPAs, change controls and complaints.


* Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) related to cell based product manufacturing or cell processing.


* Perform analysis on quality indicati...