Process Technician (Inspection and Packaging)

Working under the Team Leader, the Process Technician is responsible for the manufacturing processes of inspection and packing (I&P) at Seqirus Liverpool by executing manufacturing operations in accordance with written procedures. This position is for an operator with the necessary skills and behaviours to achieve core 3 level. Therefore, subject matter expert and people leading experience/aptitudes are relevant in candidate criteria selection. The role holder will help provide the technical skill set necessary to manufacture high quality vaccines in a compliant, efficient, and cost-effective manner.

Works in a safe manner in compliance with all pertinent UK legislation, Seqirus mandatory policies, guidelines, and site procedures. When manufacturing, ensures 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.
• Develop and coach team members and shift to success.
• Continuous improvement and use of appropriate lean tools.
• Ensure compliance to health and safety regulations, consistently demonstrating the behaviours necessary to create a safe working environment for themselves and their colleagues.
• Maintain the production team’s and site standards in EHS, cGMP, productivity, and costs, including reporting and escalation of incidents in a timely manner.
• Actively maintain and promote a cGMP compliant culture, ensuring that the highest standards of housekeeping and safety are applied within the area in accordance with regulations.
• Apply the principles of lean manufacturing, problem solving, 5S, waste elimination and energy efficient activities in support of continuous improvement.
• Execute manufacturing-lead tasks during equipment qualification and process validation in accordance with site procedures and compliance with all safety and quality (cGMP) requirements.
• Participate in investigations (safety, quality, or other incidents) related to the I&P operation, working with various stakeholders to identify and correct the root cause and implement preventive actions to reduce the possibility of reoccurrence.
• Work with the Team Leader to resolve issues encountered while executing manufacturing tasks by providing improvement recommendations.
• Maximise individual contribution so that team objectives are achieved.
• Work as a team member, providing and receiving support and feedback to team members and their Team Leader.
• Communicate and liaise with members of other teams, customers, and suppliers to meet the business’s objectives.
• Flexibly support other departments when required, providing adequate training is received and it is safe to do so.
• Suggest solutions to issues which may arise.
• Ensure that documentation is completed compliantly and in a timely manner.
• Extract and interpret batch and system performance data e.g., SAP & GLIMS to enable timely problem solving and root cause analyses.
• Attend all compulsory and allocated training courses required for the role, ensuring 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.

The role holder will be able to demonstrate the application of the skills required for their role.

Knowledge, Skills & Competencies

• Previous experience in inspection or packaging of aseptic products held within a cold chain preferred.
• Good personal qualities and interpersonal skills such as concern for standards, integrity, communication, and discretion.
• Competent in the daily use of computer systems, e.g., SAP & GLIMS.
• Demonstrated knowledge of cGMP (and FDA requirements a plus).
• Basic mechanical aptitude or knowledge of electronic/mechanical equipment.

Experience Requirements

• Relevant experience and competence in cGMP and sterile product Inspection & Packaging operations in Biotech or Pharma industry preferred, ideally within Inspection and Packaging.
• Experience of Groninger, Brevetti or Marchesini machines advantageous.
• Relevant Degree Qualification preferred.