GSK Ulverston is looking to recruit a Process Engineer/ Process Safety Engineer to provide management of Process Safety and other aspects of EHS at the Ulverston Site. This individual will also support day to day support of compliant manufacture across the site promoting the highest levels of Process Safety Management and Good Manufacturing Practice.
• Lead the implementation of the department’s Process Safety Plan.
• Provide Process Safety advice, direction and support for any projects.
• Support the programme management and delivery of Process Hazard Reviews (PHR) and technical safety reviews on an API Pharmaceutical Process Plant and Utilities.
• Lead, coordinate and support Process Safety risk assessments such as HAZOP, HAZID and HAC.
• Development, implementation & monitoring of Process Safety targets and metrics.
• Provide process engineering support for Product Lifecycle Management, including input to Technical Risk Assessment (and escalation), development and use of Product Control Strategies for new and mature products, Product Performance Monitoring and assessment, and maintenance of knowledge management associated with dose/product form.
• Provide technical leadership in the application of process engineering best practice, principles and process safety on a variety of key projects across site, including new product introduction, global supply and process capability improvements to the supply chain.
• Use of GPS tools such as RCA to problem solve Technical issues related to the dose/product form
• Support technology transfer for respective products from R&D into GMS and subsequent transfers to other GMS/third party sites
• Lead process improvement projects on site, ensuring appropriate technical change control to deliver robust, sustainable solutions
• Execute key technical activities including trials, improvement projects, RCAs, validation activities where appropriate
• Lead/support design and development work in support of equipment selection, installation and validation (including business process change) and support the standardisation of manufacturing and process measurement technology (e.g. PAT) on site
• Support the identification of Critical Process Parameters (CPP) for all new and existing products, to ensure appropriate control systems are in place for robust process operations. Where applicable, liaise with process measurement technology (PMT) experts to understand the relationship between measurement, impact of variability in raw materials and intermediates, environmental conditions, equipment conditions, manual operations and their integration with the control strategy.
• Ensure compliance with site standard operation procedures
• Ensure that GMP, Quality, Health and Safety processes are adhered to in all aspects of role
• Work with other site functions to ensure appropriate technical capability is in place e.g. operational staff
Minimum Level of Job-Related Experience required
• Experience of Pharmaceutical/FMCG or other regulated industry
• Chartered member of Institute of Chemical Engineers (ICHEME) or equivalent, or working towards chartership
• Experience of working in a regulated environment
Why is this Level of Experience Required? To have the right level of knowledge and experience to drive process understanding and continuous improvement
Key skills required
• Clear awareness of process safety risks
• Track record of improving products, processes and trouble-shooting
• Experienced in technology transfer, with an understanding of the product development process
• Able to evaluate potential innovative technology areas relevant to product
• Proven track record of expertise in delivery of technical risk assessments
• Knowledge of GMP requirements
• Knowledge of Quality by Design and risk management approaches
• Knowledge and experience of using statistics, data analysis, MSA, DoE
• Ability to contribute to and effectively influence matrix teams and colleagues in other functions
• Operational knowledge of manufacturing equipment
• Experience desirable in process measurement technology, automation/control systems, statistical process control or chemometrics
• Project management skills