Aseptic Process Lead
Estimated Salary: €70,000 - €100,000 per annum
About the Role
We are seeking a highly experienced Aseptic Process Lead to join our Biopharmaceutical organization in Carlow. As a key member of our operations team, you will be responsible for supporting Aseptic excellence and Sterility assurance in our manufacturing site.
Responsibilities
* Offer cross-functional expertise to the operations team, guiding them in the aseptic manufacture of biologics and vaccines to meet company objectives.
* Act as a Center of Excellence (COE) in the Sterile Council and Sterile Community of Practice (CoP), contributing valuable insights to shape network-wide sterile standards and guidelines.
* Support the training and development needs of team members, designing and maintaining effective training programs.
* Collaborate with the team to set objectives aligned with site goals, fostering an environment of continuous improvement and skill enhancement.
* Provide constructive feedback to enhance aseptic manufacturing processes, both formally and informally, and oversee the qualification of the IPT operations team in aseptic practices.
* Lead the planning and execution of media fill (Process Simulation) activities, ensuring thoroughness and compliance.
* Contribute to maintaining cleanroom operations and adherence to contamination control standards (cGMP) in all daily activities.
Requirements
* 3-5 years operations experience in a sterile manufacturing environment.
* Strong knowledge of sterile manufacturing processes in a highly regulated environment.
* Ability to coach and lead change.
* Relevant Bachelors degree in Science, Engineering or technical discipline.
Key Skills
* Aseptic process management.
* Sterile manufacturing processes.
* Cleanroom operations.
* Contamination control standards.
* Training and development.