Aseptic Process Lead
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Job Description
Role Description:
Requirements
Role Functions:
Provide crossfunctional 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.
Experience Knowledge & Skills:
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
Qualifications & Education:
Bachelor s Degree or higher preferred; ideally in a Science Engineering or other Technical discipline
Role Functions: 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. Experience, Knowledge & Skills: 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 Qualifications & Education: Bachelor s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline #LI-EL1
Employment Type
Full Time
Key Skills
