Work Schedule

Environmental Conditions

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.

Responsibilities:

• Set up and operation of aseptic filling lines in accordance to Standard Operating Procedures (SOPs)
• Manufacture pharmaceuticals in accordance to Standard Operating Procedures (SOPs) and Batch Manufacturing Records (BMRs).
• Perform Manufacturing, Filling, Packaging operational duties, e.g. line clearance, In Process Checks (IPC) checks, replace components on line, complete batch & associated documentation, right first time for accordance with SOPs to ensure compliance with cGMP.
• Set equipment to ensure minimum downtime levels, minimum product damage/waste, support machine start-up, changeovers, testing and cleaning activities in accordance with SOP's and cGMP requirements.
• Monitoring equipment status and readiness for production, reporting any faults or issues to Supervision
• Cleaning and maintenance of clean rooms/equipment to SOPs, cGMP and pharmaceutical industry regulatory standards.
• Perform Clean In Place (CIP) and Steam In Place (SIP) activities using HMI controlled systems.
• Operation of airlocks, autoclaves, automated vessels/ equipment cleaning systems to ensure that all equipment is sterilised ready for use. 
• To ensure any instances of non-conformance are communicated to the area leader, Manager or Quality Assurance representatives to ensure that they are investigated and rectified.
• Support project validation work, new product introduction to the Operations department
• SAP transactions.
• Using Quality systems for GMP changes and report writing.
• Conduct and assist, where appropriate in basic equipment maintenance.

Minimum Requirements/Qualifications:

• Experience of working in a pharmaceutical, or other regulated environment (MHRA and FDA regulations)
• Experience of clean room working, knowledge of aseptic manufacturing, filling desirable.
• Experience of spray drying systems, bulk GMP powder manufacturing and powder filling.
• Strong competency in English and Maths is essential, and a scientific background essential (e.g. A-Levels).
• Degree in Science based subject desirable.
• Excellent communication and team working skills, with the ability to manage your own workload.
• Experience in Lean systems and Continuous Improvement
• Understanding of HMI driven pharmaceutical systems
• Aseptic block licence.