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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 indicating data and identifying trends. Ability to identify/remediate gaps in processes or systems with correct follow up by effectiviness checks.
• Ensure connection between recurrent deviations and process robustness activities, perform trending and feed the organization based on lessons learned from investigations.
• Collaborates 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 Masters Degree in the aforementioned or related fields is preferrable.
• 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.#RPOAMS