Qa micro associate car t gent

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.

• key 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.

• 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.

Key Capabilities, Knowledge, And Skills:

 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.

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