Have you ever wondered what it is like to work in a Biotech before it goes into full scale production? Well this could just be the role for you.
This company is small at present but has a massive global presence in the biotech space. They are growing out of their site in Sligo town and now require a Microbiology Specialist – Cleanroom Upgrade. They have already been recognised as a great place to work and the future looks extremely bright for this hidden gem in Sligo.
Reporting to the QC Manager, this pivotal role will be responsible for overseeing and implementing the transition of certain cleanrooms classification and upgrades supported by the QC manager. In addition, the Microbiology Specialist 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 biopharmaceutical EU GMP plant.
RoleLead & manage the project to upgrade certain cleanroom environments.Develop & implement a detailed action plan, including timelines, resource allocation, cost, & risk management strategies.Ensure all microbiological practices comply with GMP & Department of Agriculture, Food & the Marine requirements, & any other relevant regulations.Conduct regular audits & inspections to maintain high standard of cleanliness and 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's) qualification activities as per the guidance of Annex 1 for new and existing equipment that is 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 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.RequirementsBachelor's degree in Microbiology, Biotechnology or equivalent. Master's degree is desirable.Min 5 years' experience in a similar role, ideally in a biopharmaceutical manufacturing facility (experience in 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.Advanced knowledge of MS Excel, Word and PowerPoint.Fluent in written and spoken English.
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