Work Schedule
Other
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, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
When you’re part of Thermo Fisher Scientific, you’ll do exciting 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 of pharmaceutical products in accordance with Standard Operating Procedures (SOPs) and Batch Manufacturing Records (BMRs))
- 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.
- Perform Manufacturing, Filling, inspection and packaging operational duties, ensuring compliance with current Good Manufacturing Processes (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, maintain and perform environmental monitoring of 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.
- Engage with Practical Process Improvement activities and seek to find a better way every day.
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 proficiency in English and Math, with a scientific background (e.g., A-Levels).
- Equivalent experience in a Science-based subject is also acceptable.
- Excellent communication and collaboration 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 70,000 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.