Aseptic Process Lead
AMC21235
Contract – 11 months
Carlow


We’re currently recruiting for an exciting opportunity with a Biopharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

In this role you will be responsible for supporting Aseptic excellence and Sterility assurance in a biopharmaceutical manufacturing site in Carlow.

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 dicipline

• 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.