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



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