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 join Thermo Fisher Scientific, you will engage in exciting work and belong to a group that values quality, innovation, and strong performance. As a member of a growing global company, you will be motivated to deliver your best. With $20 billion in revenue and the top R&D investment in the industry, we provide our employees with resources and chances to develop meaningful contributions worldwide.
Position Summary:
This role provides daily operational support to the team leader and manager. It also leads the setup and operation of bulking or filling activities for pharmaceutical products. These tasks follow Batch Manufacturing Records (BMRs), Standard Operation Procedures (SOPs), and Good Manufacturing Practice (GMP) regulations.
Responsibilities:
- Complete and lead operations tasks for preparation, bulking, filling and inspecting.
- Complete all activities to acquire and maintain a minimum of a Bronze license badge to permit access to Production areas (Grade C/D) access.
- Perform basic equipment maintenance and track equipment status, reporting any faults or issues to supervision.
- Clean, maintain, and perform environmental monitoring of clean rooms/equipment to regulatory standards.
- Support project validation work and new product introduction.
- Use Quality systems for investigations, GMP changes and report writing.
Leadership Responsibilities:
- Support translation of the production plan into executable tasks and allocate to team members as appropriate.
- Act as Subject Matter Expert and first point of contact to troubleshoot issues and report to advise or advance to team leaders for further investigation or remediation.
- Role model, train, assess and support the team in GMP, GDocP, EHS, and operational behaviors, ensuring adherence to site, corporate, and regulatory guidelines.
- Maintain and keep track of equipment condition and readiness for operations, tracking progress and downtime for trending purposes.
- Be responsible for generation of timely, accurate, and compliant paperwork, electronic records, and system updates. This includes BMR reviews, reconciliations, and MRP transactions.
- Encourage engagement with continuous improvement initiatives for improving efficiency. Support efforts to make tasks easier and reduce waste or costs.
- Support the Production Coordinator and act as their deputy when required.
Qualifications/Experience:
- Experience of working in a pharmaceutical or other regulated environment. Experience of clean room working and knowledge of aseptic manufacturing, filling desirable.
- Strong proficiency in English and Maths is essential, and a scientific background is required (e.g. A-Levels).
- Experience of supervision, developing, and training team members.
- Excellent communication and collaboration skills, with the ability to manage your own workload.
- Experience in Lean systems and Continuous Improvement (green belt would be desirable).
- Understanding of pharmaceutical systems controlled by human-machine interfaces.