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Sterile Microbiologist Expert
2 weeks ago
The Senior Microbiologist will provide an effective microbiological and analytical service to the sterile biologics facility, ensuring that Microbiological procedures and requirements are met. This person will join a growing site that is a state-of-the-art Biologics Sterile Fill-Finish liquid and lyophilized product in a vial format.
About the Role:
The Senior Microbiologist will be responsible for implementing the facilities sterility assurance program and microbiological support activities (facility design, filling of sterile product and aseptic practices). They will lead and implement microbiological and analytical services to meet and maintain all requirements for aseptic processing, facility design, and filling of sterile product. Additionally, they will oversee the EM and utilities program process, aseptic programme, and contamination control strategy in a multiproduct facility.
Main Responsibilities:
- Provide microbiological/sterility assurance/technical governance of in-process and finished product per product requirements.
- Understand regulations and business processes required to maintain AbbVie's and cGMP requirements for sterile product, inclusive of facility design, cross-contamination controls, microbiological laboratory standards, and data integrity.
- Define and update procedures for site relative to microbiological and environmental monitoring.
- Interface with regulatory and corporate inspectors/auditors.
- Carry out training as per training plan to support facility sterility assurance program.
- Adheres to and supports all EHS & E standards, procedures, and policies.
Requirements:
- Bachelor Degree qualification in biology or microbiology.
- A thorough knowledge of aseptic and sterile processes together with experience within a GMP environment and knowledge of current EU/FDA/ICH/HPRA and Annex 1 guidelines.
- Minimum 3-5 years' experience in microbiology is a requirement & working in a sterile/aseptic/pharma environment is a distinct advantage.
