Biomanufacturing Operations Engineer (cGMP)

Commonwealth Scientific and Industrial Research Organisation; Melbourne; On-site; AUD 76,000 - 96,000; Full time

Job summary

CSIRO is seeking a Regulated Operations Engineer to provide hands-on engineering support for a cGMP biomanufacturing facility. You will be responsible for equipment qualification, validation, and facility improvements to ensure safe, compliant operations.

Join CSIRO’s National Vaccine and Therapeutics Laboratory and collaborate with engineers, scientists, and quality specialists to support clinical trial materials production and strengthen Australia’s biomanufacturing capability.

Qualifications

• Bachelor’s degree in engineering or equivalent experience.
• Experience in operations, validation and facility management within cGMP pharmaceutical manufacturing facilities.
• Knowledge of HVAC, clean utilities and EMS.
• Understanding of GMP and GDP principles, and regulatory expectations (i.e. TGA).
• Experience with equipment qualification and IQ/OQ/PQ.
• Strong problem-solving and written communication skills.

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

Analytical thinking

Troubleshooting

Written communication

Cross-functional collaboration

GMP/GDP knowledge

Education

Bachelor's degree in engineering

Tools

TrackWise

Veeva

ACE

eQMS

Job description

CSIRO is seeking a Regulated Operations Engineer to provide hands-on engineering support for a cGMP biomanufacturing facility. You will be responsible for equipment qualification, validation, and facility improvements to ensure safe, compliant operations.

Join CSIRO’s National Vaccine and Therapeutics Laboratory and collaborate with engineers, scientists, and quality specialists to support clinical trial materials production and strengthen Australia’s biomanufacturing capability.