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 Pattern – 2 shifts on, 2 days off, 3 shifts on, 2 days off, 2 shifts on, 3 days off, etc.. Shifts will rotate between Day shift, 6.45am to 7pm, and Night shifts 6.45pm to 7am
• 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

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