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Aseptic Process Lead

4 months ago

Dublin, Dublin City, Ireland Tandem Project Management Ltd. Full time

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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