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 process’s

• Author/approve Change controls and MEDs documents as appropriate

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

Contact
Please contact Charlie Bigger on 01 5927867 or email or simply click the apply button.
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