Lead Technical Operator (AVI/Pack Team)

Work Schedule

Other

Environmental Conditions

Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, No contact lens allowed; prescriptive glasses will be provided, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

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 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 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 to 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 for 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

• EDMS author and approver status for document updates

Leadership Responsibilities:**

• Ensure the weekly inspection/packing plan is understood by the team, and activities in the production area are organised to achieve agreed targets and measures of performance:

• Ensure equipment status and readiness for inspection & packing are effectively monitored and maintained - this will include cleaning of equipment and area - and any faults or issues are reported.

• Timely preparation of material requisitions and returns, ensuring effective line operation and accurate batch record documentation..

• Timely escalation of all issues that cannot be resolved.

• Ensure inspection and packing lines are set up in accordance with the Batch Record (BMR), ensuring availability of relevant materials and equipment (where applicable).

• Supervise environmental monitoring (where applicable).

• 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.

• Effective team leadership in line with GMP requirements and company rules, policies, and procedures.

• 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.

• Provide additional leadership where appropriate in the absence of the Production Coordinator (where applicable).

• Leading by example with a one-team focus

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.