Work Schedule

Environmental Conditions

Job Description

Shift Pattern: Night Shifts - 6.45pm to 7am - Sunday evening to Friday morning

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.

Position Summary:

This role provides daily operational support to the Supervisor & Area Manager.

Responsibilities:

• Set up and operation of the Bulk Formulation, Filling, inspection & packing lines (Sterile and non-Sterile processes) in accordance to Standard Operating Procedures (SOPs)

• Manufacture, Filling, Inspection and packing pharmaceuticals (Sterile & non-sterile) in accordance to Standard Operating Procedures (SOPs) and Batch Manufacturing Records (BMRs)

• Perform Bulk Formulation, Filling, inspection & 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 Bulk Formulation, Filling, inspection & packing reporting any faults or issues to Supervision

• Cleaning and maintenance of clean rooms/equipment to SOPs, cGMP and pharmaceutical industry regulatory standards

• Perform Clean In Place (CIP) and Steam In Place (SIP) activities using HMI controlled systems

• Operation of airlocks, autoclaves, automated vessels/ equipment cleaning systems to ensure that all equipment is sterilised ready for use

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

  • Ensure equipment status and readiness for Bulk Formulation, Filling, 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.

  • Operation of airlocks, autoclaves and automated vessel and equipment cleaning systems to ensure that all equipment is sterilised and maintained in accordance with GMP and other regulatory standards.

  • 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 on line reviews, reconciliations and MRP transactions, 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 prep areas and clean rooms 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 manufactured, filled, inspected and packed and documentation completed in accordance with GMP and Standard Operating Procedures.

• Support 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.

• Ensure aseptic licence is kept up to date (as required).

• Take ownership, accountability and enforcing good GMP and GDP within the GMP facility.

EH&S:

• Understand emergency procedures and comply with safe systems of work.

• Ensure compliance with environment, 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 aseptic manufacturing, filling desirable

• Strong competency in English and Maths is essential, and a scientific background essential (e.g. A-Levels)

• Has supervised previously or has experience of developing individuals

• Excellent communication and team working 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

• Aseptic block licence