Working under the Team Leader, the Process Technician is responsible for executing the manufacturing processes in the Formulation department in accordance with written procedures.

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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

Carry out all formulation 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.

Formulation – Specific Tasks Include:

Carries out process operations such as formulation, buffers, MF59 bulk and MF59 sterile filtration using cGMP, MES, EBR as required, whilst in full compliance with local SOPs, HSE risk management systems & procedures. Thereby achieving the production schedule and requirements of the F&B area .
Moves materials required in F&B (pallet trucks, mobile vessels, rigs, raw mats, etc.) using cGMP, MES, EBR systems as required, and in full compliance with local SOPs and HSE risk management systems & procedures. In order that the production schedule and requirements of the F&B area are met.
Carries out basic area cleaning as required to maintain EM, cGMP and HSE standards in the F&B area.
Performs in Process Control checks and Environmental Monitoring so that process operations are maintained in control and products made in specification.
Completes documentation to the required standards of accuracy, timeliness, and cGMP compliance, including raising work orders and HSE incident reports. Might be able to provide first response on PCS, MES, SAP issues and exceptions.

Experience Requirements

Skilled worker with relevant experience in pharmaceutical, biotechnology sterile production. Preference given to candidates with technical training in a biotech program.
Experience of gowning or working to a minimum Grade C Cleanroom environment
Experience of Aseptic processing e.g. sterile connections, filter testing preferable
Experience of cleaning cycles for both mobile and fixed Vessels (CIP/SOP and SanIP/SOP)
Proven knowledge of cGMP. Computer competent (e.g., PCS, GLIMS, SAP, MES).

Our Benefits

CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join CSL Seqirus.

About CSL Seqirus CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about CSL Seqirus.We want Seqirus to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL Seqirus.

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CSL Seqirus | Process Technician (Formulation)