Posted 4 days ago
Sr formulation Technician (18 months Fixed-Term Contract)
AI Summary
Operates and sets up bulking and aseptic filling lines in a GMP cleanroom, manufacturing pharmaceuticals per SOPs and batch records, performing CIP/SIP and equipment cleaning, and supporting validation and new product introduction on a rotating 24/7 shift pattern.
About this role
Work Schedule
OtherEnvironmental 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, Loud Noises (Equipment/Machinery), Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materialsJob Description
Working shift pattern: 24/7 – 2 shifts on, 2 days off, 3 shifts on, 2 days off, 2 shifts on, 3 days off, etc.. Shifts will rotate between Day shift, 6.45am to 7pm, and Night shifts 6.45pm to 7am.
Contract Type: Fixed Term Contract (18 months)
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 operate bulking and or aseptic filling lines in accordance with Standard Operating Procedures (SOPs).
- Complete all activities to acquire and maintain as a minimum a Bronze license Badge – Production areas (Grade C/D) access. Maintain the Bronze license through successful requalification every 2 years.
- Manufacture pharmaceuticals following SOPs and Batch Manufacturing Records (BMRs).
- Perform Manufacturing, Filling, and Packaging operational duties, ensuring compliance with cGMP.
- Set equipment to minimize downtime and product damage/waste, supporting start-ups, changeovers, and cleaning activities.
- Monitor equipment status and report any faults or issues to Supervision.
- Clean and maintain clean rooms/equipment to regulatory standards.
- Perform Clean In Place (CIP) and Steam In Place (SIP) activities.
- Operate airlocks, autoclaves, and automated equipment cleaning systems.
- Communicate instances of non-conformance for investigation and rectification.
- Support project validation work and new product introduction.
- Perform SAP transactions and use Quality systems for GMP changes and report writing.
- Conduct basic equipment maintenance as needed.
Requirements:
- Experience in a pharmaceutical or regulated environment (MHRA and FDA regulations).
- Experience in clean room working, with knowledge of aseptic manufacturing and filling desirable.
- Experience in spray drying systems, bulk GMP powder manufacturing, and powder filling.
Skills
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