Aseptic Process Lead
AMC21235 - Contract, 11 months - Carlow
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We are currently recruiting for an exciting opportunity with a Biopharmaceutical organization based in Carlow. This is an excellent position for individuals looking to join a leading multinational renowned for their expertise.
Key Responsibilities:
* 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.
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.