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Manufacturing Process Specialist

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Dublin, Dublin City, Ireland Elusav Recruitment Full time
Job Description:

Elusav Recruitment is pleased to present an exciting opportunity for a Production Operator to join a leading global Pharma and Biopharma company in Dublin. This role involves undertaking manufacturing operations involved in the production of biologic drug substance on designated shifts.

Main Responsibilities:
  1. Collaborate with the manufacturing operations group, project design team, CQV team, and Automation/CSV representatives to develop and validate manufacturing facilities.
  2. Support equipment design, HAZOP reviews, and room programming.
  3. Work closely with the Operations team to consistently deliver Key Performance Indicators (KPIs), such as EHS metrics, Production Plan, OEE, compliance, and team training.
  4. Execute commercial manufacturing processes according to established work instructions and Standard Operating Procedures.
  5. Develop SOPs/Electronic Batch Records.
  6. Adhere to Right First-Time principles.
  7. Provide assistance and support to maintenance, engineering, quality, or other colleagues as needed.
  8. Elevate issues to the Process Lead when necessary.
  9. Liaise with other groups to ensure planning of tasks is effective and linked to the manufacturing process plan.

Requirements:
  1. A minimum of a Level 7 qualification in a science or engineering discipline, or a Level 6 with at least 2 years' experience in a GMP manufacturing requirement.
  2. Knowledge of applying Lean Six Sigma and Lean methodologies in a workplace environment.
  3. Experience in a highly regulated pharmaceutical manufacturing environment is desirable.
  4. Start-up experience in a large-scale commercial drug substance facility is advantageous but not essential.
  5. A good understanding of Upstream/Downstream Processing and relevant experience are considered beneficial.