Production Specialist

4 days ago

Sligo, Sligo, Ireland beBeeManufacturing Full time €55,000 - €85,000
Manufacturing Engineer

We are looking for an experienced Manufacturing Engineer to support our manufacturing operations. As a key member of our engineering team, you will be responsible for ensuring compliance with safety, regulatory, and organizational requirements.

Main Responsibilities:
  • Develop and modify procedures to support manufacturing operations
  • Participate in process, equipment, and facilities validations efforts and project implementations
  • Review and approve commissioning, qualification, and validation protocols for completeness and accuracy
  • Lead Process FMEAs for Visual Inspection Establish, lead, and optimize the process for certification of technicians for visual inspection
  • Establish and maintain defect libraries, execute trending processes for visual inspection defects
  • Ensure site procedures align with Global Guidance Documents and Regulatory Requirements
  • Provide technical input for SOP development and leadership of manufacturing and validation activities during project life cycles

Requirements:

  • A relevant third-level qualification in an engineering, science, or technical discipline (Degree Level or Master's Preferable)
  • At least three years of total combined experience in Technical/Operations/Quality or equivalent in a Pharmaceutical and Health Care Organization
  • Previous experience in manufacturing processes of biotechnological drugs, parenteral drugs, solutions preparation, fill finish, Lyophilisation, sterilisation operations preferable
  • Experience in clean utilities is desirable

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