AVIPack Technical Operator (5 positions available)

Work Schedule

Environmental Conditions

Job Description

Working shift pattern: 24/7 rotating day and night shifts

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 $20 billion in revenue and the industrys 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 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

• 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 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.