MSAT Process Specialist

Whenyourepart of Thermo Fisher Scientificyoulldo challenging work and be part of a team that values performancequalityand innovation. As part of a successful growing globalorganizationyou will be encouraged to perform atyour best. With revenues of $20billion 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 theProductionteam in delivering the following:

• Equipment and process establishment

• Process documentation generation and approval.

• Transfer andleveragingof existing process knowledge into the SWC systems.

• Supporting the implementation and delivery of effectivesafeand compliant production manufacturing operations within the agreed organisation framework.

• Ensuring the process for products to be manufactured is set up andmaintainedin accordance withGMP 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 andestablishingrobust lean compliant processes as all stages of the project.

• Liaising with clients and suppliers asappropriate andbecoming a key customer of the clients person in plant.

• Supporting the implementation of staff training and development programmes to assure competency (suitably qualified and experienced personnel) and support the achievement ofobjectives.

• Working as an effective member of the project team liaising with other SMEs asappropriate todraw inexpertise.

• Troubleshooting manufacturing filling inspection packaging processes to improve fields.

• Tracking improvements preventing troubleshooting solutions to key stakeholders.

• Complete all activities to successfullyacquireandmaintainaBronzelicenseBadge 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 andcomply withsafe systems of work.

• Ensure compliance with environment health and safety rulessignageand instructionsat 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 oftheend to endmanufacturing filling inspection of aseptic processes (liquidspowdersandlyophilisation) 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 soundrisk baseddecisions.

• Experience in lean/removal ofnon valueaddfrom documentation and manufacturing processes desirable.

• Experience of technical writing production documents such as DRs Protocols SOPs and BMRs

• Experience ofsupporting OE/Lean initiatives.

The role may require the holder to travel and work outside of the UK for approximatelytwo weekblocks to support equipment validation and process establishment.