Description
Role – Process Lead – SterileType – initially until end of January 2017
Location – Co. Carlow
Responsibilities:
The Lead will provide leadership, cross-functional development and technical expertise to operations team on the aseptic manufacture of biologics and vaccines at the facility, as well as ensure that objectives are effectively achieved, consistent with company’s requirements to ensure compliance, safety and reliable supply to our customers.
Principal Accountabilities:
- Responsible for the coaching, mentoring and training of the operations teams on primary aseptic manufacturing, clean room management and behaviours within the facility.
- 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.
- 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 organisational 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.
- May be required to perform other duties as assigned.
Typical Minimum Experience:
- Considerable experience and critical skills in their area of expertise that add value to the business; ideally in a manufacturing, preferably GMP setting.
- Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline
Technical
- 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
- Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner
- Strong team skills, including ability to coach/develop work teams
- Excellent training, facilitation and assessment skills
- Strategy planning and development
- Demonstrable analytical and systematic problem solving skills
- Effective time management and multi-tasking skills