About this role
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, No contact lens allowed; prescriptive glasses will be provided Job Description
Working shift pattern: 24/7 – rotating day and night shifts
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 $20 billion in revenue and the industry's largest R&D investment, we give our people the resources and opportunities to make significant contributions to the world.
We are currently hiring 5 AVI & Packaging Operators to join our growing operations team. This is a great opportunity to secure one of five available positions in a high-performing pharmaceutical environment.
Responsibilities:
• Set up and operation of the Automatic visual inspection & packing lines in accordance with Standard Operating Procedures (SOPs)
• Perform AVI and packing of pharmaceutical products (Sterile & non-sterile) in accordance with Standard Operating Procedures (SOPs) and Batch Manufacturing Records (BMRs)
• Perform AVI and Packaging operational duties, e.g., line clearance, In Process Checks (IPC) checks, replace components on line, complete batch & associated documentation, right first time in 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 inspection & packing, reporting any faults or issues to Supervision
• Cleaning and maintenance of clean rooms/equipment to SOPs, cGMP and pharmaceutical industry regulatory standards
• 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 and 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
• Tracking of progress and downtime reporting, escalating issues as appropriate.
• Accurate and timely completion of the BMR, including online reviews, reconciliations, and MRP transactions, and complete Batch Notifications as required.
• Maintenance of competency (suitably qualified and experienced) for the role through timely completion of training and, as appropriate, assessment and delivery of skills and knowledge training to others.
• Contribute towards continuous improvement initiatives both through participation and putting forward ideas and suggestions.
• Minimise material use and costs, without compromising quality, during batch running.
• Cover operational requirements in the production area as required.
GMP:
Ensure products are inspected and packed, and documentation is completed in accordance with GMP and Standard Operating Procedures.
• Support the Process Coordinator in performing Level 1 and Level 2 audits.
• Support relevant Deviation and Complaint investigations and determination of appropriate CAPA as required.
• Maintain a high level of tidiness and cleanliness at all times – personal, work area, and department.
• Take ownership, accountability, and enforce good GMP and GDP within the GMP facility.
EH&S:
• Understand emergency procedures and comply with safe systems of work.
• Ensure compliance with environmental, health, and safety rules, signage, and instructions at all times.
• Ensure prompt reporting and investigation of all accidents, near misses, and breaches of rules.
Qualifications/Experience:
• Experience of working in a pharmaceutical or other regulated environment (MHRA and FDA regulations)
• Experience of clean room working, knowledge of AVI, packaging, and serialization is highly desirable
• Strong competency in English and Maths is essential, and a scientific background is essential (e.g. A-Levels)
• Has supervised previously or has experience in developing individuals
• Excellent communication and teamwork skills, with the ability to manage your own workload
• Experience in Lean systems and Continuous Improvement (green belt would be desirable)
• Understanding of HMI-driven pharmaceutical systems
At Thermo Fisher Scientific, each one of our 120,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner, and safer.