Aseptic Process Lead

  • Carlow
  • Pe Global
The role:PE Global is currently recruiting for an Aseptic Process Lead on behalf of a leading pharmaceutical company based in Carlow. This is an initial 11-month contract role. Responsibilities: Provide cross-functional development and technical expertise to operations team on the aseptic manufacture of biologics and vaccines for our site. Ensure that objectives are effectively achieved, consistent with our company requirements to ensure compliance, safety and reliable supply to our customers.Serve as COE in Sterile Council and Sterile CoP and provide input to network sterile standards and guidelinesSupport team member training/development needs and ensure all receive appropriate trainingDevelop and maintain training programsAssist the team with development of objectives and ensures alignment with site goalsFoster an environment that allows for progressive, continuous improvement of skills and honest, open feedback focused on how/why to complete aseptic manufacturing processProvide ongoing formal and informal feedback on the Aseptic qualification of the IPT operations teamEffectively lead the media fill (Process Simulation) development and executionResponsible for contributing to the Cleanroom Operation and contamination (cGMP) in the performance of day to day activities and all applicable job functions. Education and Experience: Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline3 – 5 year’s operations experience in a sterile manufacturing environmentDemonstrated ability to coach and lead changeStrong Knowledge of Sterile Manufacturing Processes with a focus on delivery and results within highly regulated controlled environmentExceptional communication/interpersonal skills and ability to communicate to multiple levels within company Interested candidates should submit an