Team Horizon is seeking an experienced Sterility Assurance Lead to join our clients team at their manufacturing facility in the Connaught region. This is a permanent position.
Why you should apply:
* Excellent opportunity to join an established & growing company as an integral & key member of the team where you will lead & manage projects.
* Competitive Salary & Benefits package on offer.
What you will be doing:
* 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 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.
* Coordinating 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.
* Partner with EHS to ensure proper use and maintenance of PPE to protect employees from microbiological and chemical hazards.
What you need to apply:
* Bachelor’s degree in Microbiology, Biotechnology or equivalent.
* In-depth knowledge of GMP regulations and guidelines. Specific knowledge of aseptic process simulations, cleanroom qualifications and deep understanding of Annex 1 guidance.
* Expertise in microbiological testing, environmental monitoring and contamination control.
* Excellent project management and organisational skills.
* Strong leadership skills – this role requires leading a multidisciplinary team to achieve Grade A classification.
* Excellent problem solving, analytical and decision-making abilities, particularly to troubleshoot and address microbiological deviations and non-conformities.
* Strategic thinker with proven ability for forward planning.
* Strong communication and interpersonal skills. Flexible and agile in support of site’s overall mission.
* Minimum of 5 years’ experience in a similar role, ideally in a biopharmaceutical manufacturing facility.
* Experience with cleanroom validation and qualification processes.
* Experience managing and coordinating site environmental monitoring programs.
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