Aseptic Process Lead

Summary: An Aseptic Process Lead is required for a biopharmaceutical company in Carlow. The successful candidate will be responsible for supporting Aseptic Excellence and Sterility Assurance onsite.

Responsibilities: Provide cross-functional development and technical expertise to operations team on the aseptic manufacture of biologics and vaccines for the site. Ensure that objectives are effectively achieved, consistent with our Client's requirements to ensure compliance, safety and reliable supply to the customers. Serve as COE in Sterile Council and Sterile CoP and provide input to network sterile standards and guidelines. Support team member training/development needs and ensure all receive appropriate training. Develop and maintain training programs. Assist the team with development of objectives and ensures alignment with site goals. Foster an environment that allows for progressive, continuous improvement of skills and honest, open feedback focused on how/why to complete aseptic manufacturing process. Provide ongoing formal and informal feedback on the Aseptic qualification of the operations team. Effectively lead the media fill (Process Simulation) development and execution. Responsible for contributing to the Cleanroom Operation and contamination (cGMP) in the performance of day to day activities and all applicable job functions. Qualifications & Experience: Bachelor's Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline. 3 – 5 year's operations experience in a sterile manufacturing environment. Strong Knowledge of Sterile Manufacturing Processes with a focus on delivery and results within highly regulated controlled environment.
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