Production Operator I

2 weeks ago


Stevenage, United Kingdom Autolus Full time

**Location**:

- Stevenage**Job Summary**:
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. Please note that this is a shift based role working across Sunday to Wednesday / Wednesday to Saturday. (Bi-weekly shift rotation between early - 6AM - 345PM and lates 1215PM -10PM.
- 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 (~65%)
- Additional core technical competencies;
- Cell processor set up for cell culture activities
- Cell culture sampling, counting, washing, activation, feeding & harvesting
- Cell culture Magnetic Enrichment & Depletion (MACS)
- Drug Product Visual inspection
- Process adjustments
- Labelling
- Reconciliation
- To execute non-standard &/or first-time product manufacture under supervision of Product Development / MSAT staff

Improve (20-30% time)
- Authoring of SOPs & SWI

Team
- Actively support junior staff member training & development

Demonstrated skills and competencies

E - Essential

P - Preferred

Experience
- GMP manufacturing/cleanroom experience or relevant transferable skills is essential (E)
- Shift work experience is essential (E)
- Exposure to high performance/stress conditioned work (E)

**Qualifications**:

- Further education diploma/degree (STEM) and/or previous hands-on GMP Manufacturing experience (E)

Skills/Specialist knowledge

Knowledge
- Demonstrate detailed understanding of GxP production (E) / sterile / ATMP (P)
- Demonstrate basic understanding of environmental, health & safety requirements

**Skills**:

- Time management/scheduling skills
- Risk assessment/decision making ability
- GxP Document author (SOP etc.)



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