MSAT Process Specialist

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.