*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! Reach out on LinkedIn or send your CV to Lewis.ray@skillsalliance.com