Lead Formulation Technician (Night Shifts only)

Work Schedule Third Shift (Nights) Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials Job Description Shift Pattern : Night Shifts - 6.45pm to 7am - Sunday evening to Friday morning 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.

Summary : This role provides daily operational support to the Supervisor & Area Manager.

Set up and operation of the Bulk Formulation, Filling, inspection & packing lines (Sterile and non-Sterile processes) in accordance to Standard Operating Procedures (SOPs) Manufacture, Filling, Inspection and packing pharmaceuticals (Sterile & non-sterile) in accordance to Standard Operating Procedures (SOPs) and Batch Manufacturing Records (BMRs) Perform Bulk Formulation, Filling, inspection & 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 Bulk Formulation, Filling, inspection & packing 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 Process Coordinator, Area 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 EDMS author and approver status for document updates Leadership Responsibilities: Ensure the weekly production/inspection plan is understood by the team and activities in the preparation area and clean rooms are organised to achieve agreed targets and measures of performance: Ensure equipment status and readiness for Bulk Formulation, Filling, inspection & packing are effectively monitored and maintained - this will include cleaning of equipment and area - and any faults or issues are reported. Timely preparation of material requisitions and returns, ensuring effective line operation and accurate batch record documentation. Operation of airlocks, autoclaves and automated vessel and equipment cleaning systems to ensure that all equipment is sterilised and maintained in accordance with GMP and other regulatory standards. Timely escalation of all issues that cannot be resolved. Ensure inspection and packing lines are set up in accordance with the Batch Record (BMR), ensuring availability of relevant materials and equipment (where applicable) . Supervise environmental monitoring (where applicable) . Tracking of progress and downtime reporting, escalating issues as