Job Description
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This role is with Seqirus based in Tullamarine, Melbourne offering a hybrid working model (3 days onsite).
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Seeking a Senior Validation Specialist (QC Microbiology) to provide SME leadership across method validation, method development, troubleshooting, and continuous improvement activities.
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12-month casual contract with potential for extension.
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Opportunity to work on innovative microbiology and analytical testing technologies within a highly regulated GMP environment.
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About the Company/Role:
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This role is with Seqirus based in Tullamarine, Melbourne offering a hybrid working model (3 days onsite).
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Seeking a Senior Validation Specialist (QC Microbiology) to provide SME leadership across method validation, method development, troubleshooting, and continuous improvement activities.
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12-month casual contract with potential for extension.
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Opportunity to work on cutting-edge microbiology and analytical testing technologies within a highly regulated GMP environment.
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Duties:
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Your responsibilities may include but are not limited to:
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Maintain the compliant status of the QC method validation lifecycle.
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Lead technical investigations and troubleshooting activities for QC test methods, including CAPA and Change Control actions.
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Provide SME oversight for method standardisation and robustness programs.
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Develop,



optimise and validate new and existing microbiological and analytical test methods.
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Lead and coordinate method transfer activities across sites.
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Support regulatory filings, audits and inspection readiness activities.
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Design and execute validation studies involving new technologies and QC processes.
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Review validation data, identify trends or deviations and elevate findings where required.
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Maintain awareness of emerging industry technologies, equipment and best practices.
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About You:
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Bachelor's degree in Microbiology, Biochemistry, Life Sciences or a related discipline.
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Strong microbiology and/or biochemistry background within a pharmaceutical, biotechnology, biologics or vaccine environment.
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Demonstrated experience in method validation, method development and method transfer activities.
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Strong understanding of GMP, quality systems, CAPA, deviations and Change Control processes.
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Proven troubleshooting and problem-solving capabilities within a QC laboratory environment.
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Experience supporting regulatory inspections and audits highly desirable.
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Experience with plate reader software would be advantageous.
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Excellent communication, stakeholder management and project coordination skills.
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Ability to work independently while providing technical leadership and guidance to others.
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📌 Quality Validation Specialist (South Australia)
🏢 Evolve Scientific
📍 South Australia