Acknowledgement of Country
CSIRO acknowledges the Traditional Owners of the land, sea and waters, of the area that we live and work on across Australia. We acknowledge their continuing connection to their culture and pay our respects to their Elders past and present. View our vision towards reconciliation.
Role highlights
- Support Australia’s national vaccine and therapeutics capability in a GMP‑compliant manufacturing and QC environment
- Strengthen validation and cGMP compliance readiness, supporting resolving TGA compliance findings post audit
About CSIRO
As Australia's national science agency, CSIRO is solving the greatest challenges through innovative science and technology. Many of our iconic innovations were once considered impossible until someone, just like you, joined us and took on the challenge.
Visit CSIRO.au for more information.
The opportunity
We have a dynamic and inclusive team within the Biomedical Manufacturing program and are seeking applicants for the role of Validation Engineer for a 6-month term.
As a Validation Engineer, you will provide technical validation and engineering expertise to the Regulated Operations team within CSIRO’s Biomedical Manufacturing project, part of the National Vaccine and Therapeutics Laboratories.
Supporting GMP‑compliant manufacturing and Quality Control facilities, this role is central to resolving TGA compliance findings and ensuring systems, documentation and practices meet cGMP requirements ahead of re‑inspection.
Your duties will include:
- Lead and support qualification and validation (IQ/OQ/PQ) of equipment, utilities and systems, including lifecycle documentation in line with GMP requirements.
- Ensure operational compliance with GMP, EHS and internal SOPs, including authoring and maintaining documentation such as deviations, CAPAs, SOPs and change controls.
- Support internal and external audits and inspections, including preparation of operational and technical information.
- Provide facility, plant and equipment troubleshooting, coordinating with internal teams and external vendors to resolve issues and support preventative maintenance.
- Collaborate closely with Manufacturing, Quality Assurance, Quality Control and Operations teams to support efficient and compliant facility operations.
- Apply risk‑based assessments (e.g. FMEA, HAZOP) to improve operational and validation outcomes.
Role particulars & eligibility
- Location: Clayton, Melbourne (predominantly site-based role)
- Salary: AU$100,103 - AU$113,251 per annum, plus 15.4% superannuation
- Tenure & work schedule: Specified term of 6 months. Options for part-time, job-share and flexible work arrangements can be discussed based on needs of role and individual circumstances.
- Reference: 102880
- Applications for this position are open to Australian Citizens, New Zealand Citizens, Australian Permanent Residents or you must be onshore in Australia and hold a valid working visa for the duration of the specified term (with no requirement of visa sponsorship).
- Appointment to this role is subject to provision of a national police check and may be subject to other security/medical/character requirements. Please refer to the Position Description for details.
As the successful candidate, you will bring:
Essential criteria:
- Bachelor’s degree in engineering (Mechanical, Chemical, Biomedical, or related) or equivalent relevant work experience.
- Demonstrated experience with operation, validation and/or management of GMP-regulated pharmaceutical manufacturing facilities, plants and equipment.
- Experience with facility systems (HVAC, clean utilities, EMS etc) and Equipment Qualification/Validation.
- Strong understanding of GMP, validation principles, and regulatory expectations (TGA, FDA etc).
Desirable criteria:
- Experience working in regulated manufacturing environments, preferably supporting early‑phase clinical trial manufacturing, with demonstrated knowledge of GMP standards and electronic quality management systems (e.g. TrackWise, Veeva, ACE).
- Demonstrated experience implementing, managing and validating operational procedures, facilities, and equipment, including Environmental Monitoring (EM) programs and Computer Systems Validation (CSV) for manufacturing and quality‑related systems.
- Experience supporting regulatory compliance activities, including participation in regulatory or internal audits and the ability to present operational and technical information to auditors.
- Strong problem‑solving and analytical skills, with demonstrated application of risk management tools such as FMEA and HAZOP to identify, assess and mitigate operational risk.
For full details about this role, and all criteria, please review the Position Description.
Setting you up for success
We are committed to providing a recruitment process that is fair, equitable and accessible to everyone. We recognise that individuals may have different needs, and we’re happy to discuss what adjustments to our process may help you feel safe, respected and able to participate fully. Please contact [email protected] and let us know how we can support you.
Life, benefits and flexible work arrangements
We work flexibly at CSIRO, and can discuss flexible work arrangements with you during the recruitment process. CSIRO also offers a range of leave entitlements, benefits and career development opportunities. To find out more, visit Careers at CSIRO.
Inclusion and belonging
Solving Australia's greatest challenges takes a diversity of minds and lived experiences. We know diverse teams are more effective and deliver more innovative outcomes. As an equal employment opportunity organisation, we are committed to creating diverse and inclusive teams where people feel they belong. We recognise true diversity encompasses all ages, abilities, cultures, faiths, levels of education, genders, sexualities, diversity of thought and much more. We focus on hiring people who share our values of People First, Further Together, Making it Real and Trusted.
CSIRO holds Platinum Status for the Australian Workplace Equality Index for LGBTQIA+ inclusion, and a Science in Australia Gender Equity Bronze Award.
Child safety
CSIRO is committed to the safety and wellbeing of all children and young people involved in our activities and programs. View our Child Safe Policy.
How to apply
Please apply online and submit a cover letter (maximum 2 pages) and CV that demonstrate your motivation and ability to meet the essential requirements of this role.
Applications close
12 April 2026, 11:00pm AEST
We reserve the right to close the advert early if we find a suitable candidate. We encourage you to apply early to avoid missing out on this opportunity.
