22089 – Process Engineer – Cork Contractor

Purpose

The Technical specialist will provide expert technical & engineering support within the Vaccines IPT. This role will ensure on-going optimization of the process to ensure the continued manufacture and supply of quality pharmaceutical products. Priorities of: Compliance, Supply, Strategy and Profit Plan.

Responsibilities

• Ownership, effective planning & execution of continuous improvement projects to enhance and improve the process through lean manufacturing principles.
• Participate in the equipment qualification process IQ/OQ through to PQ, including drafting of associated operational SOP’s.
• Lead and participate in problem solving teams across all areas of the IPT (e.g. reliability, Safety, Quality (e.g.CAPA/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. actions/Management Of Change/Permits/Risk assessments).
• Protocol/report authoring/execution/oversight/approval as appropriate to ensure highest Quality, Compliance and Safety standards.
• Participate and comply with the company 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.
• Provides frontline technical EHS support.
• Troubleshoot and optimize Vaccines Processing Unit Operations (Cleaning, Sterilisation, Upstream, Lyophilisation, Downstream, Buffer Preparation, PSA and Material Flow).
• Ensure highest Quality, Compliance and Safety standards.
• Participate and comply with the company D Quality Management Systems (QMS) requirements, including ownership, as relevant.
• Tactical Implementation & Support for technical process and reliability Initiative.
• Ensure supply of high-quality product through ensuring equipment availability, maximise team member performance through continuous process improvement initiatives.
• Responsible for driving a culture of Reliability and Continuous Improvement through digitally enabled continuous improvement processes.

Requirements

• Level 8 honours degree in a science, engineering or manufacturing discipline.
• 3-5 years’ experience in a highly regulated manufacturing environment in a technical or manufacturing support role.
• Evidence of Continuous Professional Development.
• Knowledge of and experience in applying Lean Six Sigma and Lean methodologies, with an understanding of regulatory and validation requirements.
• Ability to interact with multiple stakeholders.
• Demonstrated problem solving capabilities