Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $20 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world. Position Summary : Responsibilities Supporting the Production team in delivering the following: Equipment and process establishment Process documentation generation and approval. Transfer and leveraging of existing process knowledge into the SWC systems. Supporting the implementation and delivery of effective, safe and compliant production manufacturing operations within the agreed organisation framework. Ensuring the process for products to be manufactured is set up and maintained in accordance with GMP, Standard Operating Procedures and other regulatory agency requirements. Involvement in the equipment and process establishment and validation phases on through into routine commercial manufacturing. Actively working with and supporting other members of the project team in delivering the project goals. Being integral in championing and establishing robust lean compliant processes as all stages of the project. Liaising with clients and suppliers as appropriate, and becoming a key customer of the client’s person in plant. Supporting the implementation of staff training and development programmes to assure competency (suitably qualified and experienced personnel) and support the achievement of objectives. Working as an effective member of the project team, liaising with other SMEs as appropriate to draw in expertise. Troubleshooting manufacturing, filling, inspection packaging processes to improve fields. Tracking improvements, preventing troubleshooting solutions to key stakeholders. Complete all activities to successfully acquire and maintain a Bronze license Badge – Production areas (Grade C/D) access. Maintain the Bronze license through successful requalification every 2 years Maintaining required housekeeping standards at all times. EH&S: Understand emergency procedures and comply with safe systems of work. Ensure compliance with environment, health and safety rules, signage and instructions at all times. Ensure prompt reporting and investigation of all accidents, near misses and breaches of rules. Qualifications/Experience: Science or Engineering based degree. Ideally Pharmaceutical or Chemical Engineering. Understanding of the end to end manufacturing, filling, inspection of aseptic processes (liquids, powders and lyophilisation ) is essential. Experience of new facility/process start-up desirable. Aptitude for or working knowledge of mechanical and software operation desirable. Proactive approach to work with a willingness to do what needs to be done to deliver against milestones. Pragmatic / common sense approach to problem solving. Demonstrable ability to make sound risk based decisions. Experience in lean/removal of non value add from documentation and manufacturing processes desirable. Experience of technical writing, production documents such as DR’s, Protocols, SOP’s and BMRs Experience of supporting OE/Lean initiatives. The role may require the holder to travel and work outside of the UK for approximately two week blocks to support equipment validation and process establishment.