Production Operator

Operator II, Production - Stevenage - On-site, Permanent* Are you an experienced Production Operator interested in joining our biotech client that is leading the way in developing innovative CAR-T cell therapies for cancer treatment? Our client is looking for a highly motivated Operator II to join their GMP manufacturing team. This is a shift-based role that involves weekends and shifts that fall within the operating hours of 6AM-10PM. You will play a key role in ensuring the production of high-quality cell-based products while maintaining compliance with GMP regulations, safety standards and company procedures. Responsibilities: * Execute production processes and operate associated equipment in line with GMP and GDP requirements. * Maintain cleanroom environments through sterile room maintenance, hydrogen peroxide vapour gassing, and environmental monitoring (EM). * Conduct raw material transfers, particulate cleaning and disinfection, material receipt, and drug product shipment. * Accurately complete documentation and data entry, ensuring compliance with regulatory standards. * Perform cell culture activities including sampling, counting, washing, activation, feeding, harvesting, and magnetic enrichment/depletion (MACS). * Carry out aseptic manipulations in Grade A environments and meet associated BROTH qualification (OAQ) standards. * Support batch review execution and collaborate with cross-functional teams to ensure smooth workflow. * Lead or support operational deviations, process risk assessments, and continuous improvement (CI) initiatives. * Assist in the authoring and revision of SOPs, SWIs, and risk assessments to maintain process efficiency and compliance. * Provide guidance and mentoring to junior team members, supporting their training and development. * Follow all SOPs/SWI applicable & in which the individual has been trained and always act in compliance with GMP & to proactively raise any issues Required Experience * Minimum 2 years GMP manufacturing cleanroom experience * Exposure to high performance/stress conditioned work * Demonstrate detailed understanding of GxP / sterile / ATMP production * Demonstrate proficiency in environmental, health & safety requirements * Ability to follow detailed instructions and make quality-critical decisions Preferred Experience: * Experience working in a shift-based environment * Familiarity with problem-solving methodologies like Lean Six Sigma This role offers an exciting opportunity to be part of an innovative biotech company, contributing to the manufacture of next-generation cell-based therapies. If you're passionate about GMP manufacturing and eager to make a difference, we’d love to hear from you

Location: SG1, Stevenage, GB

Posted Date: 7/18/2025