Position DetailsEDUCATION Bachelor's degree in Microbiology, Biotechnology or equivalent.
Master's degree is desirable.
EXPERIENCE Minimum of 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.
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 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.
CORE COMPETENCIES 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.