Regulated Biomanufacturing Operations Engineer

Commonwealth Scientific and Industrial Research Organisation; City of Melbourne; Sur place; AUD 76 000 - 96 000; Plein temps

Résumé du poste

CSIRO’s Regulated Biomanufacturing Group is seeking a Regulated Operations Engineer to provide hands‑on engineering support in a cGMP manufacturing facility. You will lead equipment qualification, validation, and facility improvements while maintaining safety and regulatory compliance.

You will work with engineers, scientists and quality professionals to troubleshoot issues, coordinate preventive maintenance and install new equipment, ensuring reliable production of clinical materials and

Qualifications

• Bachelor’s degree in engineering (Mechanical, Chemical, Biomedical, or related) or equivalent experience.
• Experience in operations, validation and/or facility management within cGMP pharmaceutical facilities.
• Experience with facility systems (HVAC, clean utilities, EMS) and equipment qualification.
• Excellent analytical, troubleshooting, organisation and written communication skills.
• Ability to work 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 SOP development and management.
• Knowledge of risk management tools (FMEA, HAZOP).
• Experience with process control systems/building management systems (Siemens, Schneider).

Responsabilités

• 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 and CAPAs.
• Collaborate with Production, Quality Assurance, Quality Control 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, plan work to meet priorities, and support CSIRO’s broader objectives.

Connaissances

Analytical

Troubleshooting

Organisation

Written communication

Cross-disciplinary collaboration

Formation

Bachelor’s degree in engineering

Outils

eQMS TrackWise

eQMS Veeva

eQMS ACE

HVAC/EMS knowledge

Siemens/Schneider Building management

Description du poste

CSIRO’s Regulated Biomanufacturing Group is seeking a Regulated Operations Engineer to provide hands‑on engineering support in a cGMP manufacturing facility. You will lead equipment qualification, validation, and facility improvements while maintaining safety and regulatory compliance.

You will work with engineers, scientists and quality professionals to troubleshoot issues, coordinate preventive maintenance and install new equipment, ensuring reliable production of clinical materials and