Job Description

n
- This role is with Seqirus based in Tullamarine, Melbourne offering a hybrid working model (3 days onsite).
n
- Seeking a Senior Validation Specialist (QC Microbiology) to provide SME leadership across method validation, method development, troubleshooting, and continuous improvement activities.
n
- 12-month casual contract with potential for extension.
n
- Opportunity to work on innovative microbiology and analytical testing technologies within a highly regulated GMP environment.
n

n

About the Company/Role:

n

n
- This role is with Seqirus based in Tullamarine, Melbourne offering a hybrid working model (3 days onsite).
n
- Seeking a Senior Validation Specialist (QC Microbiology) to provide SME leadership across method validation, method development, troubleshooting, and continuous improvement activities.
n
- 12-month casual contract with potential for extension.
n
- Opportunity to work on innovative microbiology and analytical testing technologies within a highly regulated GMP environment.
n

n

Duties:

n

Your responsibilities may include but are not limited to:

n

n
- Maintain the compliant status of the QC method validation lifecycle.
n
- Lead technical investigations and troubleshooting activities for QC test methods, including CAPA and Change Control actions.
n
- Provide SME oversight for method standardisation and robustness programs.
n
- Develop,



optimise and validate new and existing microbiological and analytical test methods.
n
- Lead and coordinate method transfer activities across sites.
n
- Support regulatory filings, audits and inspection readiness activities.
n
- Design and execute validation studies involving current technologies and QC processes.
n
- Review validation data, identify trends or deviations and elevate findings where required.
n
- Maintain awareness of emerging industry technologies, equipment and best practices.
n

n

About You:

n

n
- Bachelor's degree in Microbiology, Biochemistry, Life Sciences or a related discipline.
n
- Strong microbiology and/or biochemistry background within a pharmaceutical, biotechnology, biologics or vaccine setting.
n
- Demonstrated experience in method validation, method development and method transfer activities.
n
- Strong understanding of GMP, quality systems, CAPA, deviations and Change Control processes.
n
- Proven troubleshooting and problem-solving capabilities within a QC laboratory environment.
n
- Experience supporting regulatory inspections and audits highly desirable.
n
- Experience with plate reader software would be advantageous.
n
- Excellent communication, stakeholder management and project coordination skills.
n
- Ability to work independently while providing technical leadership and guidance to others.
n

#J-18808-Ljbffr

📌 QUALITY VALIDATION SPECIALIST (Williamstown)
🏢 Evolve Scientific
📍 Williamstown