QA Micro associate

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.

Learn more at you ready to be part of an innovative and hardworking venture that is changing the landscape of blood cancer treatment CAR-T therapy harnesses the patients own immune system to combat cancer cells providing hope to those who have exhausted other treatment options. As we are expanding our capacity for CAR-T treatments in Europe we are seeking dedicated individuals to join

As a QA Micro Associate CAR-T Europe you will play a pivotal role in ensuring the microbiological and aseptic oversight of the production of autologous CAR-T products for clinical trials and commercial operations which takes place in a controlled cGMP cleanroom environment fostering contamination control and adhering to industry-specific regulations. This position is based in Ghent Belgium.

You will be responsible for:

• 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 sites 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.

Qualification and requirements:

• A minimum of a Bachelors Degree in Engineering Science or an equivalent technical field.
• Experience in the biological and/or pharmaceutical industry with relevant micro experience related to manufacturing.
• 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.
• 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!

At Johnson & Johnson we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear fair and respectful of your time.

Heres what you can expect:

• Application review: Well carefully review your CV to see how your skills and experience align with the role.
• Getting to know you: If theres a good match youll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.
• Staying informed: We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.
• Final steps: For successful candidates you will need to complete country-specific checks before starting your new role. We will help guide you through these.

Required Skills:

Preferred Skills: