Aseptic Process Specialist
4 days ago
Company Overview:
We're a leading biopharmaceutical organization based in Ireland, committed to excellence in sterile manufacturing. Our team is passionate about delivering high-quality products that meet the needs of our customers.
Job Description:
We're 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 offer cross-functional expertise to the operations team, guiding them in the aseptic manufacture of biologics and vaccines to meet company objectives.
Key Responsibilities:
- 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.
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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