Lead Technical Operator (AVIPack Team)

Work Schedule

Environmental Conditions

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 youre part of Thermo Fisher Scientific youll 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 SOPs 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 120000 extraordinary minds has a unique story to tell. Join us and contribute to our singular missionenabling our customers to make the world healthier cleaner and safer.