Technical Operator - Double Day Shift
Fisher Clinical Services
Swindon, United Kingdom
5d ago

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 :

  • Join our Double Day shift to 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.
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