21235 – Process Engineer – Aseptic Lead – Carlow Contractor

Process Engineer – Aseptic Lead

PurposeR

esponsible for supporting Aseptic Excellence/ Sterility Assurance.

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.

Requirements

• Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline
• 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