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Manufacturing Support Specialist (Clean Room Controls)

Reference:POR875810
Location: Limerick
Qualification:Degree
Experience:3-4 Years
Job Type:Permanent
Salary:Not Disclosed
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May be suitable for: Microbiologist

A Manufacturing Support Specialist (Clean Room Controls) is required to join a rapidly expanding Global Biopharmaceutical business in Limerick. This is an opportunity to develop your career with an award-winning business that develop life-changing medicines for serious diseases. This position will report into Manufacturing to provide leadership and direction for clean room contamination control in support of all manufacturing programs; including, but not limited to the manufacturing process and associated clean utilities, qualification and validation activity, microbial sampling/testing practices, data trending, and investigations. Oversees the Manufacturing microbial control for commercial manufacturing production in addition to implementation of improvements.


The Role

  • Ensures that all manufacturing clean room controls are in compliance with cGMP guidelines and applicable regulations.
  • Reviews and provides feedback on area procedures, including SOP’s, master batch documentation, change controls, and validation protocols/reports in accordance with cGMP standards.
  • Chairs reoccurring and ad-hoc cross functional teams in support of manufacturing microbial control initiatives
  • Documents and investigates quality events associated with contamination control of commercial manufacturing to ensure effective root-cause analysis, corrective action plans determination, product impact, and remediation.
  • May develop and deliver microbial control training.
  • Prepares reports and metrics by collecting, analyzing, and summarizing information and trends.
  • Makes decisions; develops and implements policies.
  • Implements preventive and corrective actions to enhance clean room controls.
  • Participates in regulatory inspections and any required follow up actions.

The Person
  • Bachelors degree in Microbiology, Biology or related field
  • 3+ years of relevant cGMP manufacturing experience.
  • Knowledge and experience in pharmaceutical microbiology, cell culture manufacturing, clean utilities, clean room design and operations, and microbial sampling and testing techniques.

For further details please contact; Paula O’Reilly on 087 7094141 or send CV in confidence to paula.oreilly@lifescience.ie




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