Work Schedule
7 1/2 hr shift
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, Loud Noises (Equipment/Machinery), Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift
Job Description
Working shifts: 24/7 rotating between day shifts (7:00 to 19:00) and night shifts (19:00 to 7:00) following this pattern: 2 shifts on, 2 days off, 3 shifts on, 2 days off, 2 shifts on, 3 days off.
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.
* Strong competency in English and Math, with a scientific background (e.g., A-Levels) essential.
* Equivalent experience in a Science-based subject is also acceptable.
* Excellent communication and teamwork skills, with the ability to manage workload.
* Experience in Lean systems and Continuous Improvement.
* Understanding of HMI driven pharmaceutical systems.
* Aseptic block license.
At Thermo Fisher Scientific, every single one of our 100,000+ remarkable individuals has an unusual narrative to reveal. Become a part of our outstanding mission and contribute to our customers' ability to make the world healthier, cleaner, and safer.
#J-18808-Ljbffr