Process Engineer (Aseptic Lead) - Carlow, Ireland - 11-Month Contract
With worldwide demand for their life-changing oncology treatment increasing; one of our global pharmaceutical clients is looking for a Process Engineer to join their team to support multiple capital projects taking place onsite in Leinster.
This is a fantastic opportunity to work on a state-of-the art fill-finish facility and the company's first stand-alone vaccine and biologics plant outside the US.
Role Summary:
1. 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.
2. Serve as COE in Sterile Council and Sterile CoP and provide input to network sterile standards and guidelines.
3. Support team member training/development needs and ensure all receive appropriate training.
4. Develop and maintain training programs.
5. Assist the team with development of objectives and ensures alignment with site goals.
6. Foster an environment that allows for progressive, continuous improvement of skills and honest, open feedback focused on how/why to complete aseptic manufacturing process.
7. Provide ongoing formal and informal feedback on the Aseptic qualification of the IPT operations team.
8. Effectively lead the media fill (Process Simulation) development and execution
9. Responsible for contributing to the Cleanroom Operation and contamination (cGMP) in the performance of day-to-day activities and all applicable job functions.
Requirements:
10. 3 - 5 year's operations experience in a sterile manufacturing environment
11. Demonstrated ability to coach and lead change.
12. Strong Knowledge of Sterile Manufacturing Processes with a focus on delivery and results within highly regulated controlled environment
If this role is of interest to you, please apply now
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