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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 provides and supports a high degree of assurance that specific processes will consistently produce and meet its pre-determined specifications by deploying process validation, process system engineering, data architecture, continuous process verification, and process investigation.
The Process Investigator provides 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, following up on various departmental post-implementation optimizations, and tracking 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 to ensure smooth alignment and handling of complex investigations, while acting as the shopfloor single point of contact for particulate matter investigations:
o Be the SPOC for QC particulate matter review regarding the Ghent manufacturing site.
o 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 indicating data and identify trends. Ability to identify/remediate gaps in processes or systems with correct follow-up by effectiveness checks.
* Ensure connection between recurrent deviations and process robustness activities, perform trending and feed the organization based on lessons learned from investigations.
* Collaborate with functional departments to resolve issues.
* Contribute to cross-functional projects/teams with many stakeholders.
* Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements.
* Require minimal direction to complete tasks, knows how to get resources and information from established internal contacts; consult with manager for decisions outside established processes.
* Provide guidance to other employees in the interpretation of quality issues and participate in the development of technical or scientific initiatives and activities.
* Routinely recognize and resolve quality issues. Seek management guidance on complex issues.
* Drive continuous quality improvements.
* Act as delegate for Investigation Lead responsibilities upon request.
Qualifications & Requirements:
* A Bachelor’s degree in Molecular Biology, Cell Biology, Biochemistry or related area in the Life Sciences is required. A Master’s Degree in the aforementioned or related fields is preferable.
* Experience in an industrial manufacturing or regulated environment is required.
* Strong working knowledge of current Good Manufacturing Practices (cGMP).
* Experience working in a controlled, cleanroom environment under aseptic conditions is required.
If you’re ready to take on this exciting challenge and help us drive quality in the innovative field of CAR-T therapy, we would love to hear from you! Join us in making a difference — together we can elevate laboratory excellence and improve lives.
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