Process Investigator

Johnson & Johnson is currently seeking a Process Investigator to join our Manufacturing Science & Technology CAR-T EMEA organization located in Gent, Belgium.

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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/.

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.
Key Responsibilities:

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.
Qualifications

Education:


* 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

Required:


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


* 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.


* 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.


* P...