Work Schedule

Third Shift (Nights)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials

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