CSL Plasma
Process Technician Campaign (Inspection and Packaging)
At a glance
Location: US-NY-Liverpool Map
Posted: 11/08/2021
Closing: 12/07/2021
Degree: Not Specified
Type: Full-Time
Experience: Not Specified
CSL Plasma
Job description
Job Description

Working under the Team Leader, the Process Technician is responsible for the manufacturing processes of inspection and packing (I&P) at Seqirus Liverpool by the executing manufacturing operations in accordance with written procedures.

This role will provide manufacturing support, during commissioning and qualification, in the preparation of manufacturing instructions, processes and procedures.  

The role holder will help provide the technical skill set necessary to manufacture high quality vaccines in a compliant, efficient, and cost effective manner.  

This role is responsible to prepare documentation (SOPs, Manufacturing Instructions and Risk assessments) and ensure these procedures are in line with approach defined by the Team Leader. 

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.

  • Ensure compliance to health and Safety regulations.  Consistently demonstrating the behaviours necessary to create a safe working environment for themselves and their colleagues.

Maintains the production team’s and site standards in EHS, cGMP, productivity and costs.  This includes reporting and escalation of incidents in a timely manner. 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 regulations and to apply the principle lean Manufacturing, problem solving, 5S, waste elimination and energy efficient activities in support and continuous improvement.

Execute manufacturing-lead tasks during commissioning (e.g., FAT and SAT), equipment qualification and process validation.  The tasks will be executed in accordance with the site procedures and in compliance with all safety and quality (cGMP) requirements.  Participates in investigations (safety, quality or other incidents) related to the I&P operation.  Works with the various stakeholders to identify and correct the root cause and implement preventive actions to reduce the possibility of reoccurrence.

This role works with the Team Leader to resolve issues encountered while executing manufacturing tasks by providing improvement recommendations.  Subsequently, this role works with other stakeholders and process operators to implement the corrective action.  To maximise their individual contribution so that team objectives are achieved.  To work as a team member, providing and receiving support feedback to team members and their Team Leader. To communicate and liaise with members of other teams, customers and suppliers 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.  To suggest solutions to issues which may arise.     

Ensures that documentation is completed compliantly and in a timely manner.  Extracts and interprets 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.  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.

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

  • Local language

Education Requirement

Relevant Degree Qualification preferred

Experience Requirements

1+ years experience and competence in cGMP and sterile product production operations in Biotech or Pharma industry preferred, ideally within Inspection and Packaging

This advert is for multiple positions within the new £40million Fill Finish Expansion

Please note - to bypass an in-person Assessment Centre, there is a 20 minute online assessment as part of the application process

About Us

Our Benefits

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 Seqirus.

About Seqirus

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

We want Seqirus to reflect the world around us

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

Do work that matters at Seqirus!

Process Technician Campaign (Inspection and Packaging)