Job Description
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 SOPs. Lead and participate in problem solving teams across all areas of the IPT (e.g. reliability, Safety, Quality (e. 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 processs. 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 Skills: Lyophilisation Upstream Downstream