Associate Operator, Production
Job Description
This job is with Autolus Therapeutics, an inclusive employer and a member of myGwork – the largest global platform for the + business community. Please do not contact the recruiter directly.
Role Summary
This role sits within the Production team at Autolus where there is a shared mission of manufacturing and delivering Autologous products to our patients.
• This is a shift base role within a dynamic, bright, enthusiastic and evolving team.
• The role will be based on site, within the Autolus Manufacturing site(s) in Stevenage, however, may occasionally involve travel to other sites.
• Must meet the requirements of working in a cleanroom/ aseptic environment
Key Responsibilities
• To demonstrate initiative & work as a flexible & motivated team member
• To follow all SOPs/SWI applicable & in which the individual has been trained
• To act at all times in compliance with GMP & to proactively raise any issues
• To act in a safe manner at all times (in compliance with the Health & Safety at work act & all other relevant legislation) & to use the appropriate reporting systems to highlight potential hazards
• To stay up to date with all training requirements as identified in the job holders training plan
• To participate in continuous improvement (CI), root cause analysis (RCA) & corrective & preventative (CAPA) activities within span of influence
Role specific -
Make
• To routinely execute production processes & operate associated process equipment in accordance with GMP & GDP to produce high quality cell-based products, inc.;
o Timely & accurate document completion & management
o Isolator Hydrogen Peroxide Vapour Gassing
o Clean/sterile room maintenance
o Clean Room Environmental Monitoring (EM)
o Raw Material Transfers
o Particulate cleaning & disinfection
o Material receipt & drug product shipment
o Data entry
o Documentation archiving
• To ensure that processes, process areas & equipment are never compromised by non-adherence to GMP
Communication
• To work effectively with colleagues (inc. different functions) to ensure the smooth flow of materials & information before, during & after production activities
Improve
• To use understanding of processes & equipment to support day to day trouble shooting and the identification & progression of improvement activities
• To update or amend safety & process risk assessments, SOPs, SWI etc to facilitate rapid, controlled cycles of improvement
• To take on additional roles within the team, as agreed with the individual’s manager & in accordance with the Team Plan
Team
• Accountable for ownership of own development & training
Demonstrated skills and competencies
E – Essential
P –
Experience
• GMP manufacturing/cleanroom experience or relevant transferable skills is not essential but is (P)
• Shift work experience is strongly (P)
• Exposure to high performance/stress conditioned work (P)
Qualifications
• Ability to read, write & perform arithmetic at a suitable level (E) – GCSE Mathematics & English or equivalent.
• Computer Literate (E)
• Further education diploma/degree (STEM) and/or previous hands-on GMP Manufacturing experience (P)
Skills/Specialist knowledge
Knowledge
• Good understanding of GxP / sterile / ATMP production (P)
Skills
• Confident user of MS Office applications inc., Teams, PowerPoint, Excel & Word (P)
• Familiarity with problem solving methodologies and/or lean six sigma (P)
Behaviours
• Attention to detail (E)
• Ability to precisely follow instructions & procedures (E)
• Ability to make quality-critical decisions (E)
• Good communication, organisation, teamwork (E)
• Curious to learn with a can-do attitude (E)
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