Job Description
Experienced Sterility Assurance Lead required to manage microbiological practices, conduct audits, design environmental monitoring programs, and lead aseptic process simulation activities in a biopharmaceutical EU GMP plant in Sligo. The ideal candidate will have a strong understanding of microbiology, relevant regulations, and experience with validation and qualification of manufacturing equipment, HVAC systems, and critical systems in a GMP environment. They will be responsible for ensuring high standards of cleanliness and sterility, analyzing environmental monitoring data, identifying trends, and taking corrective actions as necessary. Additionally, they will develop and implement robust environmental monitoring programs, design and conduct aseptic process simulations, and support the project to upgrade cleanroom environments from Grade D to Grade A classification. The successful candidate will have excellent communication and leadership skills, with the ability to provide training on microbiological techniques, environmental monitoring, and GMP requirements. They will also be responsible for drafting, reviewing, and updating SOPs related to microbiological practices, cleanroom operations, and environmental monitoring. The role requires collaboration with Operations, Quality, Engineering, and TSA to ensure microbiological quality throughout the manufacturing process. The successful candidate will have a strong background in microbiology, relevant regulations, and experience with validation and qualification of manufacturing equipment, HVAC systems, and critical systems in a GMP environment. They will be responsible for ensuring high standards of cleanliness and sterility, analyzing environmental monitoring data, identifying trends, and taking corrective actions as necessary. Additionally, they will develop and implement robust environmental monitoring programs, design and conduct aseptic process simulations, and support the project to upgrade cleanroom environments from Grade D to Grade A classification. The role requires excellent communication and leadership skills, with the ability to provide training on microbiological techniques, environmental monitoring, and GMP requirements. They will also be responsible for drafting, reviewing, and updating SOPs related to microbiological practices, cleanroom operations, and environmental monitoring. The successful candidate will have a strong background in microbiology, relevant regulations, and experience with validation and qualification of manufacturing equipment, HVAC systems, and critical systems in a GMP environment. They will be responsible for ensuring high standards of cleanliness and sterility, analyzing environmental monitoring data, identifying trends, and taking corrective actions as necessary. Additionally, they will develop and implement robust environmental monitoring programs, design and conduct aseptic process simulations, and support the project to upgrade cleanroom environments from Grade D to Grade A classification. The role requires collaboration with Operations, Quality, Engineering, and TSA to ensure microbiological quality throughout the manufacturing process. The successful candidate will have a strong background in microbiology, relevant regulations, and experience with validation and qualification of manufacturing equipment, HVAC systems, and critical systems in a GMP environment. They will be responsible for ensuring high standards of cleanliness and sterility, analyzing environmental monitoring data, identifying trends, and taking corrective actions as necessary. Additionally, they will develop and implement robust environmental monitoring programs, design and conduct aseptic process simulations, and support the project to upgrade cleanroom environments from Grade D to Grade A classification. The role requires excellent communication and leadership skills, with the ability to provide training on microbiological techniques, environmental monitoring, and GMP requirements. They will also be responsible for drafting, reviewing, and updating SOPs related to microbiological practices, cleanroom operations, and environmental monitoring. The successful candidate will have a strong background in microbiology, relevant regulations, and experience with validation and qualification of manufacturing equipment, HVAC systems, and critical systems in a GMP environment. They will be responsible for ensuring high standards of cleanliness and sterility, analyzing environmental monitoring data, identifying trends, and taking corrective actions as necessary. Additionally, they will develop and implement robust environmental monitoring programs, design and conduct aseptic process simulations, and support the project to upgrade cleanroom environments from Grade D to Grade A classification. The role requires collaboration with Operations, Quality, Engineering, and TSA to ensure microbiological quality throughout the manufacturing process. The successful candidate will have a strong background in microbiology, relevant regulations, and experience with validation and qualification of manufacturing equipment, HVAC systems, and critical systems in a GMP environment. They will be responsible for ensuring high standards of cleanliness and sterility, analyzing environmental monitoring data, identifying trends, and taking corrective actions as necessary. Additionally, they will develop and implement robust environmental monitoring programs, design and conduct aseptic process simulations, and support the project to upgrade cleanroom environments from Grade D to Grade A classification. The role requires excellent communication and leadership skills, with the ability to provide training on microbiological techniques, environmental monitoring, and GMP requirements. They will also be responsible for drafting, reviewing, and updating SOPs related to microbiological practices, cleanroom operations, and environmental monitoring. The successful candidate will have a strong background in microbiology, relevant regulations, and experience with validation and qualification of manufacturing equipment, HVAC systems, and critical systems in a GMP environment. They will be responsible for ensuring high standards of cleanliness and sterility, analyzing environmental monitoring data, identifying trends, and taking corrective actions as necessary. Additionally, they will develop and implement robust environmental monitoring programs, design and conduct aseptic process simulations, and support the project to upgrade cleanroom environments from Grade D to Grade A classification. The role requires collaboration with Operations, Quality, Engineering, and TSA to ensure microbiological quality throughout the manufacturing process. The successful candidate will have a strong background in microbiology, relevant regulations, and experience with validation and qualification of manufacturing equipment, HVAC systems, and critical systems in a GMP environment. They will be responsible for ensuring high standards of cleanliness and sterility, analyzing environmental monitoring data, identifying trends, and taking corrective actions as necessary. Additionally, they will develop and implement robust environmental monitoring programs, design and conduct aseptic process simulations, and support the project to upgrade cleanroom environments from Grade D to Grade A classification. The role requires excellent communication and leadership skills, with the ability to provide training on microbiological techniques, environmental monitoring, and GMP requirements. They will also be responsible for drafting, reviewing, and updating SOPs related to microbiological practices, cleanroom operations, and environmental monitoring. The successful candidate will have a strong background in microbiology, relevant regulations, and experience with validation and qualification of manufacturing equipment, HVAC systems, and critical systems in a GMP environment. They will be responsible for ensuring high standards of cleanliness and sterility, analyzing environmental monitoring data, identifying trends, and taking corrective actions as necessary. Additionally, they will develop and implement robust environmental monitoring programs, design and conduct aseptic process simulations, and support the project to upgrade cleanroom environments from Grade D to Grade A classification. The role requires collaboration with Operations, Quality, Engineering, and TSA to ensure microbiological quality throughout the manufacturing process. The successful candidate will have a strong background in microbiology, relevant regulations, and experience with validation and qualification of manufacturing equipment, HVAC systems, and critical systems in a GMP environment. They will be responsible for ensuring high standards of cleanliness and sterility, analyzing environmental monitoring data, identifying trends, and taking corrective actions as necessary. Additionally, they will develop and implement robust environmental monitoring programs, design and conduct aseptic process simulations, and support the project to upgrade cleanroom environments from Grade D to Grade A classification. The role requires excellent communication and leadership skills, with the ability to provide training on microbiological techniques, environmental monitoring, and GMP requirements. They will also be responsible for drafting, reviewing, and updating SOPs related to microbiological practices, cleanroom operations, and environmental monitoring. The successful candidate will have a strong background in microbiology, relevant regulations, and experience with validation and qualification of manufacturing equipment, HVAC systems, and critical systems in a GMP environment. They will be responsible for ensuring high standards of cleanliness and sterility, analyzing environmental monitoring data, identifying trends, and taking corrective actions as necessary. Additionally, they will develop and implement robust environmental monitoring programs, design and conduct aseptic process simulations, and support the project to upgrade cleanroom environments from Grade D to Grade A classification. The role requires collaboration with Operations, Quality, Engineering, and TSA to ensure microbiological quality throughout the manufacturing process. The successful candidate will have a strong background in microbiology, relevant regulations, and experience with validation and qualification of manufacturing equipment, HVAC systems, and critical systems in a GMP environment. They will be responsible for ensuring high standards of cleanliness and sterility, analyzing environmental monitoring data, identifying trends, and taking corrective actions as necessary. Additionally, they will develop and implement robust environmental monitoring programs, design and conduct aseptic process simulations, and support the project to upgrade cleanroom environments from Grade D to Grade A classification. The role requires excellent communication and leadership skills, with the ability to provide training on microbiological techniques, environmental monitoring, and GMP requirements. They will also be responsible for drafting, reviewing, and updating SOPs related to microbiological practices, cleanroom operations, and environmental monitoring.