Lead Formulation Technician (Night Shifts only)

Work Schedule

Environmental Conditions

Job Description

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

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.

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 SOPs 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