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Production Operator

Skills Alliance Enterprise
Stevenage
1 week ago
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Recruitment Consultant at Skills Alliance Enterprise

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 ashift-basedrole 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

Seniority level

  • Seniority levelNot Applicable

Employment type

  • Employment typeFull-time

Job function

  • Job functionProduction
  • IndustriesPharmaceutical Manufacturing and Biotechnology Research

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