Regulated Operations Engineer

Acknowledgement of Country

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Role highlights

• Support GMP manufacturing and QC operations for clinical trial material production.
• Lead equipment qualification, process validation, and continuous improvement initiatives.
• Collaborate with cross-functional teams to ensure regulatory compliance and technical excellence.

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.

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The opportunity

Join CSIRO as a Regulated Operations Engineer and contribute to Australia's biomedical manufacturing capability.

In this role, you'll support the operation of a GMP-compliant manufacturing and QC laboratory facility producing clinical trial materials for Phase 1 and 2 studies. You'll work closely with multidisciplinary teams to provide engineering support across equipment qualification, process validation, and facility operations, ensuring compliance with regulatory standards and internal quality systems.

This is a hands-on, collaborative role suited to engineers with experience in regulated environments who are passionate about continuous improvement and technical excellence in support of national health priorities.

Your high-level duties will include:

• Support troubleshooting and resolution of facility, plant and equipment issues impacting production.
• Establish project specifications by studying facility design, customer requirements, performance standards and completing technical studies.
• Author and execute commissioning or validation protocols (IQ/OQ/PQ) for equipment, utilities, and systems as required.
• Execute requalification activities and maintain validation lifecycle documentation in compliance with GMP and regulatory expectations.
• Assist in the design, installation, and commissioning of new equipment and facility upgrades.
• Provide technical support in facility boundaries during tech transfers and scale-up activities.

Role particulars

Location and office arrangements: Melbourne (Clayton), VIC

Salary: AU$131, AU$153,639.00 per annum (pro rata for part-time), plus 15.4% superannuation

Tenure & work schedule: Indefinite; full time

Reference: 101310

As the successful candidate, you will bring:

• Bachelor's degree in engineering (Mechanical, Chemical, Biomedical, or related) or equivalent relevant work experience.
• Demonstrable experience (minimum 5 years) 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.
• Demonstrated ability to undertake original, creative and innovative research by generating and pursuing novel ideas and solutions to scientific research problems.
• Experience of providing technical support to the design, development, and implementation of new projects.
• Strong understanding of GMP, validation principles, and regulatory expectations (TGA, FDA etc).

For full details about this role, and other criteria, please review the Position Description.

Not sure if you meet all the criteria?

While it is CSIRO policy that the successful candidate must meet all the essential criteria, there are many ways to demonstrate this. Don't let the list discourage you. If you are unsure about applying, please reach out to the contact person in 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 it may be helpful for us to adjust our process to make it equitable for your individual situation. Please contact Cristina O'Brien via email at and let us know how we can support you.

Life at CSIRO and flexible work arrangements

We work flexibly at CSIRO, offering a range of options for how, when and where you work. We 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 Gold Status for the Australian Workplace Equality Index for LGBTQIA+ inclusion, and a Science in Australia Gender Equity Bronze Award.

Eligibility

Applications for this position are open to Australian Citizens, New Zealand Citizens, Australian Permanent Residents currently residing in Australia. Appointment to this role is subject to provision of a national police check and may be subject to other security/medical/character requirements.

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

Monday 3rd November, 11:00pm AEST