Technical Specialist - Shift

Technical Specialist - Shift About the Company My client is a world leader in their Industry and this site has been a major part of the community and pharmaceutical sector in Cork. They specialize in the development and commercial supply of bio tech medicines, innovative vaccine development and testing immuno-oncology products. About the Position As a Technical Specialist, you will work with the Integrated Product Team (IPT) 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. Key Responsibilities Bring energy, knowledge, innovation to carry out the following: Lead and participate in problem solving teams across all areas of the IPT (e.g. reliability, Safety, Quality (e.g. CAPA/CLUE/QNs 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) Review and coordinate review of electronic batch records and associated supporting documentation for batch release. Troubleshoot issues which may arise during shift cycle and implement MPS problem solving techniques and complete associated documentation to support resolution. Support batch progression and trend downtime to understand root cause and improvement opportunities for future downtime prevention initiatives. Protocol/report authoring/execution/oversight/approval as appropriate Ensure highest Quality, Compliance and Safety standards Participate and comply with the our company's 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 Provide SME support to the shift and day teams as required. 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 processs Author/approve Change controls and MEDs documents as appropriate Experience/Requirements In order to excel in this role, you will more than likely have: Level 8 honours degree in a science or engineering discipline 3-5 years Engineering/Technical experience within a GMP Environment preferred 3-5 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 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 will require the successful candidate to work shift (4-Cycle Shift). Remuneration Package A competitive package is available including generous salary and benefits. Contact Please contact on or simply click the apply button. To view all live jobs with Brightwater and market insights, please visit our website