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y of activities in their area of work.
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, 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 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 behaviors 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
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
This is a 12 month secondment opportunity
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 inclusion and belonging. Learn more about Inclusion & Belonging at CSL.
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