Sterile Manufacturing Lead

5 days ago


Dublin, Dublin City, Ireland Life Science Recruitment Full time

About Us:

We are a Biopharmaceutical organization dedicated to delivering innovative solutions in sterile manufacturing. Our team is driven by a passion for excellence and a commitment to customer satisfaction.

Job Summary:

We are seeking an experienced Aseptic Process Lead to join our team in Carlow. In this role, you will be responsible for supporting Aseptic excellence and Sterility assurance in our biopharmaceutical manufacturing site. You will work closely with the operations team to ensure the aseptic manufacture of biologics and vaccines meets company objectives.

Key Responsibilities:

  • Act as a subject matter expert in sterile manufacturing processes and contribute to the development of network-wide sterile standards and guidelines.
  • Design and implement effective training programs to support the development needs of team members.
  • 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 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.

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 Bachelor's degree in Science, Engineering, or technical discipline.


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