Autolus is seeking a highly motivated Operator II to join our GMP manufacturing team. This shift-based role involves weekend working and operates across 6 AM – 10 PM. 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.

SKILLS & EXPERIENCE

• Minimum 2 years of GMP manufacturing cleanroom experience (essential).
• Experience working in shift-based, high-performance environments (preferred).
• Strong understanding of GxP, ATMP production, QMS, and environmental health & safety requirements.
• Ability to follow detailed instructions, work with attention to detail, and make quality-critical decisions.
• Proficiency in Microsoft Office (Word, Excel, Teams, PowerPoint) and familiarity with problem-solving methodologies like Lean Six Sigma (preferred).
• Excellent communication, teamwork, and organizational skills.

As an Operator II, you will:

• 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.