Production Operator - GMP-regulated environment

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

• Contribute to the manufacture of innovative biologic therapies for early-stage clinical trials.

• Work in a specialised GMP pilot-scale manufacturing facility at Clayton.

• Join a multidisciplinary team supporting Australia’s growing biotechnology sector.

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

Join CSIRO’s Regulated Biomanufacturing team and play a hands-on role in producing high-quality biologics for Phase 0, Phase 1 and Phase 2 clinical trials. Working within our GMP pilot-scale manufacturing facility, you will support projects for Australian and international researchers, biotechnology companies and biopharmaceutical organisations. This is an opportunity to build your expertise across upstream and downstream bioprocessing while contributing to the development of innovative therapies with real-world health impact.

As the Production Operator, you will undertake manufacturing activities spanning media and reagent preparation, mammalian cell culture, bioreactor scale-up, filtration, chromatography, viral reduction, tangential flow filtration and bioconjugation. You will work closely with Quality Assurance, Quality Control and Regulated Operations colleagues to deliver safe, efficient and compliant manufacturing outcomes.

Your high-level duties will include:

• Perform upstream and downstream manufacturing activities, including media and buffer preparation, cell culture, bioreactor operations, chromatography, filtration and bioconjugation.
• Execute manufacturing processes in accordance with batch records, SOPs, cGMP requirements and production schedules.
• Monitor process parameters, conduct in-process checks and maintain accurate and timely production and quality documentation.
• Operate, clean, maintain and troubleshoot production, laboratory and cleanroom equipment and facilities.
• Identify and report quality events, contributing to deviation investigations, CAPAs, risk assessments and continuous improvement activities.
• Support equipment commissioning, validation and re-validation, as well as internal, client and regulatory audits.
• Collaborate with Quality Assurance, Quality Control and multidisciplinary teams to support the development and manufacture of biologics for clinical trials.

Role particulars

Location: Clayton, Melbourne VIC, Relocation assistance may be provided to the successful candidate if required.

Salary: AU$76k - AU$96k per annum + 15.4% superannuation

Tenure & work schedule: Indefinite, Full-time

Reference: 104624

As the successful candidate, you will bring:

Essential

• Bachelor’s degree or equivalent relevant work experience in Biotechnology, Cell Culture, Purification or process engineering.
• A minimum of 1 years' experience operating cGMP-regulated pharmaceutical, biopharmaceutical, or biologics manufacturing facilities, with a strong understanding of GMP requirements and experience working with production plant, process equipment, and associated documentation systems.
• Proven experience in recombinant protein production using mammalian cell culture and/or downstream purification processes.
• Strong interpersonal and teamwork skills, with a demonstrated ability to collaborate effectively with cross-functional teams to achieve operational, production, and quality objectives.

Desirable

• Demonstrated experience in a regulated environment with experience of cGMP standards, including electronic quality management systems (eQMS).
• Experience operating ÄKTA Ready or ÄKTA Pilot chromatography systems and/or proficiency in the use of UNICORN software for chromatography process control, monitoring, and data management.
• Demonstrated experience operating and maintaining single-use bioreactor systems such as Cytiva Wave and Xcellerex platforms.

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

Not sure of you meet this 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 Shree Chattopadhyay via [email protected] and let us know how we can support you.

Life at CSIRO and flexible work arrangements

CSIRO 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/New Zealand Citizens, and Australian Permanent Residents only. Appointment to this role is subject to the 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 CV and cover letter (maximum 2 pages) that demonstrate your motivation and ability to meet the selection criteria of this role.

Applications close

29 November 2026, 11:00 pm AEDT