LEAD MICROBIOLOGIST
Our client is dedicated to providing solutions for a healthier world—through their growing line of health products designed to help prevent, control, and treat diseases. This vaccine facility in Sligo is looking for an energetic, solutions-oriented Microbiologist to join their expanding team. This is a unique opportunity to be involved in the expansion phase of a world-class biopharma plant.
Reporting to the QC Manager, this pivotal role will be responsible for overseeing and implementing the transition of certain cleanrooms classification from Grade D to Grade A, ensuring compliance with stringent regulatory standards. In addition, the Site Microbiologist manages adherence to the classification of all remaining non-Grade A spaces. This role demands a strong self-starter with a deep understanding of microbiology and associated risks in a biopharmaceutical EU GMP plant.
KEY RESPONSIBILITIES
* Lead and manage the project to upgrade certain cleanroom environments from Grade D to Grade A classification.
* Develop and implement a detailed action plan, including timelines, resource allocation, cost, and risk management strategies.
* Ensure all microbiological practices comply with GMP and Department of Agriculture, Food and the Marine requirements, and any other relevant regulations.
* Conduct regular audits and inspections to maintain a high standard of cleanliness, sterility, and bioburden control.
* Design and implement robust environmental monitoring programs for the upgraded cleanrooms.
* Analyze environmental monitoring data, identify trends, and take corrective actions as necessary.
* Lead aseptic process simulation (APS) qualification activities as per the guidance of Annex 1 for new and existing equipment required to support aseptic processing in the upgraded cleanrooms.
* Develop and execute aseptic process simulation validation protocols and generate comprehensive aseptic process simulation validation reports.
* Experience with validation and qualification of manufacturing equipment, HVAC systems, and other critical systems in a GMP environment.
* Draft, review, and update SOPs related to microbiological practices, cleanroom operations, and environmental monitoring.
* Provide training on microbiological techniques, environmental monitoring, and GMP requirements.
* Train staff on new and updated SOPs to ensure consistent adherence.
* Coordinate on-site aseptic processing and gowning training and implement a routine requalification program.
* Implement and maintain effective contamination control strategies to prevent microbial contamination in the manufacturing process.
* Investigate and resolve microbiological deviations and non-conformities.
* Collaborate with Operations, Quality, Engineering, and TSA to ensure microbiological quality throughout the manufacturing process.
* Ability to identify potential environmental, health, and safety hazards in the microbiological lab and manufacturing environments.
* Conduct thorough risk assessments to evaluate and mitigate risks associated with microbiological and cleanroom activities.
* Partner with EHS to ensure proper use and maintenance of PPE to protect employees from microbiological and chemical hazards.
KEY QUALIFICATIONS
* Bachelor's degree in Microbiology, Biotechnology, or equivalent. Master's degree is desirable.
* Minimum of 5 years' experience in a similar role, ideally in a biopharmaceutical manufacturing facility (experience in a facility with Grade A cleanrooms and aseptic processing is highly desirable).
* Extensive experience with cleanroom validation and qualification processes.
* Experience managing and coordinating site environmental monitoring programs.
* Prior experience with cleanroom classification upgrades is highly desirable.
* Experience with regulatory, client inspections, and audits.