About the role
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Laboratory Setting, Standing for full shift
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.