Company : Johnson and Johnson Location : Ghent Flanders From : Talent BE
You will work in a controlled cGMP cleanroom environment, fostering contamination control and adhering to industry-specific regulations.
This position is based in Ghent, Belgium.
Major Responsibilities:
* Collaborate with the Process Development team, Quality, and Operations organization to uphold contamination control of the manufacturing facility in alignment with cGMP and Janssen requirements.
* Conduct aseptic qualifications of manufacturing personnel, including gowning and aseptic processing.
* Define and impart specific aseptic techniques for crucial process steps through instructor-led trainings and awareness sessions.
* Drive the Aseptic Oversight program through manufacturing floor surveillance.
* Support process microbiological investigations actively.
* Develop relevant quality control documents, Standard Operating Procedures (SOPs), and Work Instructions (WIs).
* Maintain, re-evaluate, and communicate key critical inputs for the site's environmental monitoring program.
* Identify risks and opportunities related to contamination control, collaborating closely with operators, Quality Control (QC), and operations management on improvement initiatives.
* Perform tasks in compliance with safety policies, quality systems, and cGMP requirements.
Qualifications:
* Education/Experience:
A minimum of a Bachelor's Degree in Engineering, Science, or an equivalent technical field.
Experience in the biological and/or pharmaceutical industry, with relevant micro experience related to manufacturing.
Preferably in clinical quality, method development, cell banking, cell therapy, or Research & Development.
Your offer Education/Experience:
A minimum of a Bachelor's Degree in Engineering, Science or equivalent technical discipline is required.
Experience within the biological and/or pharmaceutical industry with relevant micro experience related to manufacturing is required, preferably in clinical quality, method development, cell banking, cell therapy, or Research & Development.
* Aseptic processing in an ISO 5 cleanroom and biosafety cabinets.
* Knowledge of cGMP regulations, FDA/EU guidance, and Good Tissue Practices related to cell-based product manufacturing.
* Detailed knowledge of shop floor manufacturing processes.
* Strong organizational skills with the ability to work effectively in a team environment and a positive attitude.
* Excellent written and verbal communication skills in English.
* Record-keeping abilities in the form of notebooks, technical reports, and protocols.
* Ability to summarize and present results, and experience with team-based collaborations.
* Proactive, solution-oriented mindset with the ability to explore new paths and identify possibilities.
* Accept diversity as an asset.
* Ability to follow procedures and guidelines, even in ambiguous situations.
Our Offer:
* The opportunity to chip in to a dynamic treatment that provides hope to patients in need.
* The chance to play a role in shaping a new venture from its inception.
* An innovative working environment.
* On-the-job training specific to CAR-T therapy.
* Opportunities for continued development and growth within a robust organization.
* An open-ended contract and a competitive remuneration package.
Join us in transforming cancer treatment and making an important impact in the lives of patients.
Apply now to be part of this exciting journey! Johnson and Johnson GhentFlanders
