Senior Associate Sterility Assurance
Job Type: Full time
We are looking for a Senior Associate Sterility Assurance to join our growing project Banksia team for constructing our state-of-the-art Influenza cell-culture (FCC) manufacturing facility, with an expected completion date in2026. Based mainly at Tullamarine (Victoria, Australia), as the Sterility Assurance Subject Matter Expert you will ensure that all procedures, facilities and equipment are set up following current guidelines with a specific focus on aseptic design and contamination control principles.
Reporting to the Manager Sterility Assurance, you will
- Ensure environmental and personnel monitoring, in-process testing, finished product testing and microbial method development and documentation are properly included in the design of manufacturing processes
- Participate in validation and qualification of the facility, utility and equipment, process, personnel and method;
- Compose and coordinate the execution of Characterisation, Operational Qualification (OQ) & Performance Qualification (PQ) Environmental Monitoring Protocols
- Help design cleaning and disinfection, hygiene and gowning, aseptic behaviour, facility and process design;
- Ensure development, implementation and maintenance of sterility assurance standards and processes following global company policy, regulatory requirements and industry standards;
- Manage the generation of documents for SOPs, risk assessments, trend reports and other Sterility Assurance documentation to maintain compliance to GMP and help prepare regulatory submissions;
- Represent Sterility Assurance on site projects to help set expectations regarding sterility assurance related compliance and maintain metrics;
- Be a catalyst for change and continuous improvement in Sterility Assurance and embed Sterility Assurance culture into the new Facility from Day 1.
Your skills and experience
To be considered for this role you have:
- A bachelor's degree in Microbiology or Biology life sciences or equivalent;
- 3+ years' experience in the pharmaceutical manufacturing industry with direct experience in sterility assurance of aseptic processing;
- 3+ years' experience in sterility assurance of aseptic cleanroom facilities, their processes and equipment including design validation and monitoring, including aseptic gowning qualification;
- Experience in a role requiring interaction with regulatory authorities including submissions and inspections;
- Experience in quality assurance and regulatory compliance with cGMP, FSA, EU and other regulatory agency guidelines;
- Experience performing risk assessments for facility design, specifically relating to environmental monitoring locations for facility OQ/PQ and routine monitoring;
- Experience in a role requiring collaboration with partners at all levels, data-based decision-making and accuracy.
How to apply: Please send us your resume and covering letter (in one document), which addresses the criteria above and includes reference number R-193889 by 2 February 2023.
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