Sterility Assurance Lead

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 trouble shoot 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