- 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 environment.
- 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.
QUALITY VALIDATION SPECIALIST employer: Evolve Scientific
Join a leading pharmaceutical company in the Southeast suburbs of Melbourne, where you will be part of a dynamic team dedicated to quality and compliance. With a strong focus on employee development and a culture that promotes continuous improvement, this role offers meaningful opportunities for growth in a supportive environment. Enjoy the benefits of full-time hours, a collaborative work culture, and the chance to make a significant impact in the pharmaceutical industry.
