Regulated Biomanufacturing Operations 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’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.