Manufacturing Support Specialist (Clean Room Controls)

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.

• 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.