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.