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Process Technical Specialist
Our client, a pharmaceutical company in Cork is currently looking to recruit a Process Technical Specialist for their site.
- The role will involve providing technical & equipment support to the Vaccines Integrated Process Team (IPT).
- You will ensure on-going optimization of the process and manufacturing support to ensure the continued manufacture and supply of quality pharmaceutical products in meeting our Manufacturing Division Priorities of: Compliance, Supply, Strategy and Profit Plan.
- As a Process Technical Specialist you will work with the IPT team to ensure the effective and efficient on-time delivery of batch production within the IPT area.
- This requires the delivery of process excellence and reliability across all areas of the IPT
- Lead and participate in problem solving teams across all areas of the IPT (e.g. reliability, Safety, Quality (e.g.CAPA/DN/MDNs etc).
- Lead and close process related deviations and reports.
- Support Operations team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g. EHS metrics, Production Plan, OEE, compliance and team training.
- Provides frontline technical EHS support & coaching to the operational team and be first point of contact for safety related concerns (e.g. Entropy actions/MOC/Permits/Risk assessments).
- Protocol/report authoring/execution/oversight/approval as appropriate
- Ensure highest Quality, Compliance and Safety standards.
- Participate and comply with the company Manufacturing Division Quality Management Systems (QMS) requirements, including ownership, as relevant.
- Provide ongoing coaching and support to cross functional team members, to share process, engineering and maintenance best practices.
- Provide coaching and development to all technicians within the IPT.
- Tactical Implementation & Support for reliability equipment initiatives.
- Ensure supply of high quality product through ensuring equipment availability; maximize team member performance through continuous process improvement initiatives.
- Provide technical, process and engineering expertise within a wide range of projects within the IPT, such as the introduction of new equipment and process’s.
- Author/approve Change controls and MIDAS documents as appropriate
- Level 8 honours degree in a science or engineering discipline.
- 5 years Engineering/Technical experience within a GMP Environment preferred.
- 5 years experience in a highly regulated manufacturing environment in a technical or manufacturing support role.
- Knowledge of and experience in applying Lean Six Sigma and Lean methodologies, with an understanding of regulatory and validation requirements.
- Lean Six Sigma Green Belt desirable.
- Demonstrated successes in a team environment, such as project teams, Lean Six Sigma team, etc.
- Demonstrated problem solving capabilities
- Ability to interact with multiple stakeholders.
- This role may require you to work shift.
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