QA Micro Supervisor

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/.

CAR-T is an innovative blood cancer treatment that uses the strength of the patient's own immune system.

The patient's T-cells are genetically modified to eliminate the cancer cells.

This advanced technology offers hopeful prospects to patients for whom other therapies provide no or insufficient results.

We are therefore working passionately on expanding our capacity for CAR-T treatments in Europe, both at our existing site in Beerse and in Ghent, where we are developing a new production site.

We are looking for strong talents who are eager to participate in this innovative and hopeful venture.

The QA Micro Supervisor, CAR-T Europe is part of a team responsible for providing microbiological and aseptic oversight and contamination control of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.

The QA Micro Supervisor will be based in Ghent, Belgium and reports to the site's Plant Microbiologist.

Major Responsibilities:

• Lead a team of 4-8 FTE that ensures contamination control of the facility to manufacture products, consistent with cGMP and Janssen requirements and in collaboration with Quality Assurance/Control, Operations and MS&T organizations.

• Drive strategy improvements related to the reduction of contamination risks and the improvement of microbiological hygiene.

• Owns aseptic qualification program of manufacturing personnel (e.g.

gowning, aseptic processing).

• Drives the Aseptic Oversight program by ensuring manufacturing floor surveillance.

• Reviews and approves process microbiological investigations at the manufacturing site.

• Define specific aseptic techniques to be performed for crucial process steps through instructor-led trainings and awareness sessions.

• Write relevant QC documents, SOP's and WI's.

• Maintain, re-evaluate and communicate key critical inputs to site environmental monitoring program.

• Identify risks and opportunities in relation to contamination control and assist in follow-up initiatives for improvement in close cooperation with operators, QC and operations management.

• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.

Education/Experience:

A Master's Degree in Engineering, Science or equivalent technical discipline is required.

A minimum of 5 years experience within the biological and/or pharmaceutical industry is required,...