Manufacturing Operations Specialist

5 days ago


Co Meath, Ireland beBeeManufacturing Full time €46,550 - €62,305

Exciting opportunity for a Manufacturing Professional.

The role is responsible for overseeing all procedures and processes associated with the manufacture of Commercial Large-Scale Drug Substance at a manufacturing facility. The job entails preparation, operation, and monitoring of equipment, use of business systems, and carrying out tasks including but not limited to cleaning, validation, in-process testing, and basic maintenance of equipment in accordance with current Good Manufacturing Practices (cGMPs).

Key Responsibilities:

  • Collaborate with the manufacturing operations group, project design team, the CQV team, and the Automation/CSV representatives to facilitate the development and validation of the manufacturing facility.
  • Support Equipment Design/Hazard Operability (HAZOP) and Room Programming Reviews.
  • Contribute to the Operations team's efforts to consistently deliver on specific area Key Performance Indicators (KPIs), e.g., Environmental Health and Safety metrics, Production Plan, Overall Equipment Effectiveness (OEE), compliance, and team training.
  • Execute commercial manufacturing processes according to established work instructions and Standard Operating Procedures.
  • Generate Standard Operating Procedures/Electronic Batch Records.
  • Adhere to Right First-Time principles.
Requirements:
  • Experience in a GMP Manufacturing environment required.
  • Level 7 qualification in a science or engineering discipline.
  • Understanding of Drug Substance Manufacturing Operations beneficial.


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