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Job Summary
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.
Key Responsibilities
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.
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.
Working Pattern
- This is a shift-based role requiring weekend work.
- Shifts will fall within the operational hours of 6 AM 10 PM.
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, wed love to hear from you!
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