Filling Line Operator - Starting 9th of Feb in Liverpool

5 Month Contract working in the Filling team. 4 on 4 off shift pattern days and nights. Based in Speke in Liverpool. Working under the Team Leader, the Process Technician is responsible for executing the manufacturing processes in the Aseptic Filling department in accordance with written procedures. The role holder will provide (be trained in) the technical skill sets necessary to manufacture high quality vaccines in a compliant, efficient and cost-effective manner.

Responsibilities

• Carries out all sterile filling process operations using local SOPs and batch documentation whilst in full compliance with cGMP to meet production schedule demands.
• Work in a safe manner in compliance with all pertinent UK legislation, Seqirus mandatory policies, guidelines and site procedures for Health, Safety and Environment.
• Ensure that all Departmental SOPs and MIs are followed.
• Ensure appropriate control, monitoring and delivery of activities in their area of work.
• Ensure that all documentation is completed correctly, accurately in a timely manner and signed by the relevant personnel.
• Carry out final documentation review and sign off to ensure documentation is right first time.
• Ensure compliance to Health and Safety regulations.
• Actively maintain and promote a cGMP compliant culture, ensuring that the highest standards of housekeeping and safety are applied within the area.
• Apply the principles of Lean Manufacturing, Problem Solving, 5S, Waste Elimination and Energy Efficient Activities in support of Continuous Improvement.
• Maximise individual contribution so that team objectives are achieved.
• Work as a team member, providing and receiving feedback to team members and their team leader.
• Communicate and liaise with members of other teams in order to meet the business's objectives.
• Flexibly support other departments when required, providing adequate training is received and it is safe to do so.
• Attend all compulsory and allocated training courses required for the role.
• Ensure that all training is completed in a timely manner and that personal training records are kept up to date.
• Continue to develop new skills, competencies and behaviours to fulfil both current and future business needs.
• Contribute ideas and action in order to improve team, process and equipment performance.
• Support organisation change and process improvements.

Aseptic Filling - Specific Tasks Include:

• Movement of materials using pallet trucks (manual and electric) to ensure manufacturing operations are efficient and production demands are met.
• Cleaning and disinfection of production rooms and equipment to maintain cleanroom, cGMP and HSE standards.
• Cleaning, preparation, sterilisation, assembly and disassembly of production equipment.
• Performance of In Process Control checks and Environmental Monitoring to ensure the isolator environment is maintained and products are made within specification.
• Operation of the Filling production line including use of machine interfaces, performing VHP/CIP/SIP cycles, monitoring the batch and performing interventions.

Knowledge, Skills & Competencies

• Filling of sterile products / Aseptically qualified (e.g. sterile connections, sterility assurance).
• Attention to detail and high personal concern for standards, integrity, communication, and discretion.
• Proven knowledge of cGMP.
• Basic mechanical aptitude or knowledge of electronic/mechanical equipment.
• Competent in using multiple computer systems e.g. PCS, GLIMS, SAP and production line machine interfaces.

Education Requirements

• Relevant degree qualification preferred.

Experience Requirements

• 1+ years' experience and competence in cGMP and sterile product production operations in the Biotech or Pharma industry preferred.