Regulated Operation Engineer

CSIRO; City of Melbourne; On-site; AUD 76,000 - 96,000; Full time

Benefits offered by this job

15.4% superannuation

Job summary

CSIRO’s Regulated Biomanufacturing Group seeks a Regulated Operations Engineer to provide hands-on engineering support for the cGMP facility and quality-control labs in the National Vaccine and Therapeutics Laboratory.

You will lead commissioning, qualification, validation activities, preventive maintenance, and facility improvements while ensuring compliance with cGMP, HSE and regulatory requirements. salary AU$76k–96k plus 15.4% super.

Qualifications

• Bachelor’s degree in engineering (Mechanical, Chemical, Biomedical, or related) or equivalent relevant work experience.
• Experience working within operations, validation and/or facility management within cGMP-regulated pharmaceutical manufacturing facilities.
• Experience with facility systems (HVAC, clean utilities, EMS) and equipment qualification.
• Analytical, troubleshooting, organisation, and written communication skills.
• Ability to work collaboratively across disciplines and manage competing priorities.
• Understanding of GMP and GDP principles, and regulatory expectations (i.e. TGA).
• Experience with eQMS (TrackWise, Veeva, ACE).
• Experience with developing and management of SOPs.
• Knowledge of risk management tools (FMEA, HAZOP).
• Experience with process control systems/Building management systems (Siemens, Schneider).
• Experience with CMMS (e.g. MEX).

Responsibilities

• Provide operational support for facility, plant and equipment, including troubleshooting, alarm response, repairs and preventive maintenance coordination.
• Author and execute commissioning, qualification and validation activities (IQ/OQ/PQ) for equipment, utilities and systems, including ongoing requalification.
• Support facility improvement projects, including new equipment installations, commissioning, upgrades, risk assessments and change controls.
• Ensure activities and documentation comply with cGMP, HSE, regulatory requirements and internal procedures, including deviations, CAPAs and safety risk assessments.
• Collaborate with Production, Quality Assurance, Quality Control, Regulated Operations, vendors and other stakeholders to support effective facility operations.
• Apply technical and scientific knowledge to improve operational and validation processes and contribute to projects across multidisciplinary teams.
• Maintain a safe, clean and compliant working environment, effectively plan work to meet operational priorities, and contribute to CSIRO’s broader scientific objectives.

Skills

Engineering knowledge

GMP understanding

Troubleshooting

Analytical thinking

Written communication

Cross-functional collaboration

Problem solving

Facility systems experience

Education

Bachelor’s degree in engineering

Tools

Siemens

Schneider

eQMS TrackWise

eQMS Veeva

eQMS ACE

Job description

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 ourvision towards reconciliation.

Role highlights

• Support operations at CSIRO’s cGMP biomanufacturing facility.
• Deliver equipment qualification, validation and facility improvements.
• Help produce materials for early-phase clinical trials.

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.

The opportunity

Join CSIRO’s Regulated Biomanufacturing Group as a Regulated Operations Engineer and apply your engineering expertise in an environment where quality, reliability and scientific impact come together. You will provide hands‑on engineering support within the National Vaccine and Therapeutics Laboratory, helping to maintain the safe, compliant and efficient operation of its cGMP manufacturing facility and associated quality‑control laboratories.

Working across facility operations, equipment qualification and validation, maintenance, utilities and improvement projects, you will help troubleshoot operational issues, coordinate preventive maintenance and contribute to the installation and commissioning of new equipment and facility upgrades.

This is an exciting opportunity to work alongside engineers, scientists, quality specialists and project leaders, using your technical judgement and problem‑solving skills to support the production of clinical trial materials and strengthen Australia’s biomanufacturing capability.

Your high-level duties will include:

• Provide operational support for facility, plant and equipment, including troubleshooting, alarm response, repairs and preventive maintenance coordination.
• Author and execute commissioning, qualification and validation activities (IQ/OQ/PQ) for equipment, utilities and systems, including ongoing requalification
• Support facility improvement projects, including new equipment installations, commissioning, upgrades, risk assessments and change controls.
• Ensure activities and documentation comply with cGMP, HSE, regulatory requirements and internal procedures, including deviations, CAPAs and safety risk assessments.
• Collaborate with Production, Quality Assurance, Quality Control, Regulated Operations, vendors and other stakeholders to support effective facility operations.
• Apply technical and scientific knowledge to improve operational and validation processes and contribute to projects across multidisciplinary teams.
• Maintain a safe, clean and compliant working environment, effectively plan work to meet operational priorities, and contribute to CSIRO’s broader scientific objectives.

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

Reference: 104319

As the successful candidate, you will bring:

• Bachelor’s degree in engineering (Mechanical, Chemical, Biomedical, or related) or equivalent relevant work experience.
• Experience working within operations, validation and/or facility management within cGMP-regulated pharmaceutical manufacturing facilities.
• Experience with facility systems (HVAC, clean utilities, EMS etc) and and/ or equipment qualification.
• Analytical, troubleshooting, organisation, and written communication skills.
• Ability to work collaboratively across disciplines and manage competing priorities
• Understanding of GMP and GDP principles, and regulatory expectations (i.e. TGA).
• Experience with eQMS (e.g., TrackWise, Veeva, ACE).
• Experience with developing and management of SOPs.
• Knowledge of risk management tools (e.g., FMEA, HAZOP).
• Experience with process control systems/ Building management systems (Siemens, Schneider)
• Experience with CMMS (e.g. MEX)

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.

Applications for this position are open to Australian/New Zealand Citizens, and Australian Permanent Residents only. 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.