Responsibilities:
- Assess the maturity of the teams aseptic and clean room ability; assess team member training/development needs and ensure all receive appropriate training, resources and programs to develop technical and other skills, to effectively complete their jobs. 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. Oversee coordination of resources to implement suggestions/ideas of merit within the clean room areas.
- Effectively lead the media fill (Process Simulation) development and execution.
- Responsible for contributing to the Cleanroom Operation and contamination control procedures in IPT including but not limited to: Cleaning and Sanitisation,
- Garbing, People, Material and Process Flow, and Segregation Procedures.
- Required to comply with Merck Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
- Work collaboratively to drive a safe and compliant culture.
- Maybe required to perform other duties as assigned.
Qualification and Experience:
- Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline
- Considerable experience and critical skills in their area of expertise that add value to the business; ideally in a manufacturing, preferably GMP setting.
- Operational experience within high speed aseptic filling lines and formulations areas
- Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
- Sterile filling processes and equipment
- Pharmaceutical and Biotechnology manufacturing processes
- Proficiency in Microsoft Office and job related computer applications required
- SAP knowledge and experience preferred
- Lean Six Sigma Methodology experience desired
If interested please contact Seán on 021-4297900 or sean.molloy@peglobal.net
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