- An exciting new vacancy has arisen for an Aseptic Process Lead Engineer at our client’s busy pharmaceutical site in Co. Carlow.
- This is a newly created role that will be responsible for supporting Aseptic Excellence/ Sterility Assurance within the client’s site.
Core Duties and 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 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 IPT 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.
Minimum Qualifications and Experience:
- Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline
- In order to excel in this role, you will more than likely have:
- 3 – 5 year’s operations experience in a sterile manufacturing environment
- Demonstrated ability to coach and lead change.
- Strong Knowledge of Sterile Manufacturing Processes with a focus on delivery and results within highly regulated controlled environment
- Exceptional communication/interpersonal skills and ability to communicate to multiple levels within company.
Please note, we do not require agency assistance with this role.