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 escalate 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.
Apply! If you think this could be the role for you then please apply now! Please send us a cover letter AND a detailed resume in WORD format (PDFs can be corrupted / not processed). Or, if you have any questions, please contact Priyanka on 03 9040 1630.
With over 90 years' combined experience, NES Fircroft (NES) is proud to be the world's leading engineering staffing provider spanning the Oil & Gas, Power & Renewables, Chemicals, Construction & Infrastructure, Life Sciences, Mining and Manufacturing sectors worldwide. With more than 80 offices in 45 countries, we are able to provide our clients with the engineering and technical expertise they need, wherever and whenever it is needed. We offer contractors far more than a traditional recruitment service, supporting with everything from securing visas and work permits, to providing market-leading benefits packages and accommodation, ensuring they are safely and compliantly able to support our clients.
Submission Form
Submit your message along with your CV attached, and one of our specialists will be in touch.