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
The role is primarily based at our Stevenage manufacturing facilities, with occasional travel to other Autolus sites as required.
The role involves working in a cleanroom/aseptic environment and is subject to associated gowning, behaviour, and procedural requirements.
Previous experience is not required— full training will be provided. This is an excellent opportunity for individuals looking to start a career in advanced manufacturing or biotechnology.
* Shift patterns operate on a rotating basis and may include:
* 4-on, 3-off (Sunday–Wednesday or Wednesday–Saturday):
o Early shift: 6:00 AM – 3:45 PM
o Late shift: 12:15 PM – 10:00 PM
* 4-on, 4-off:
o Early shift: 6:00 AM – 5:00 PM
o Late shift: 11:00 AM – 10:00 PM
* Shift pattern rotations typically occur every two weeks.
• 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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