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.
To work in a safe manner in compliance with all pertinent UK legislation, Seqirus mandatory policies, guidelines and site procedures for Health, Safety and Environment.
When manufacturing ensure that all Departmental SOPs and MIs are followed and:
* 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. Consistently demonstrating the behaviours necessary to create a safe working environment for themselves and their colleagues.
To actively maintain and promote a cGMP compliant culture, ensure that the highest standards of housekeeping and safety are applied within the area in accordance with the Orange Guide and CFR regulations and to apply the principles of Lean Manufacturing, Problem Solving, 5S ,Waste Elimination and Energy Efficient Activities in support of Continuous Improvement.
To maximise their individual contribution so that team objectives are achieved. To work as a team member, providing and receiving feedback to team members and their team leader. To communicate and liaise with members of other teams in order to meet the business's objectives. When required, to flexibly support other departments - 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. To continue to develop new skills, competencies and behaviours to fulfil both current and future business needs. The role holder will be able to demonstrate the application of the skills required for their role.
To contribute ideas and action in order to improve team, process and equipment performance. To support process improvement and uphold Seqirus Values and Behaviours.
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) / Use of Isolator technology.
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
Adecco acts as an employment agency for permanent recruitment and an employment business for the supply of temporary workers. The Adecco Group UK & Ireland is an Equal Opportunities Employer.
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Salary description
£22.87 - £22.87 per hour