Operations Engineer (Process Improvement)

Federated Biologics Pty Ltd is a biologics manufacturing company based in Alexandria, Sydney. The company designs, builds, and operates manufacturing facilities for the production of biologics.

The Role

The Operations Engineer (Process Improvement) is responsible for the reliability and continuous improvement of the company's manufacturing facility, utility systems and equipment. The role focuses on reviewing maintenance workflows and processes to identify inefficiencies and areas for improvement, and on overseeing and improving how maintenance is planned, delivered and documented.

Combining preventative maintenance strategy, data analysis and continuous improvement with the coordination of shutdowns, upgrades and external contractors, the role enhances operational efficiency, reduces downtime and maintains GMP compliance. You will work closely with process engineers, automation engineers and production teams, using your technical and analytical know-how, strong communication and ruthless prioritisation to keep manufacturing running safely and efficiently.

Key Responsibilities

- Process Improvement & Efficiency: Review maintenance workflows, processes and operational systems to identify inefficiencies and areas for improvement, and drive continuous improvement initiatives across plant and equipment to reduce failure rates, extend asset life, enhance operational efficiency and reduce costs.
- Data-Driven Decision-Making: Analyse equipment, maintenance and performance data to identify reliability issues and trends, and make recommendations to improve maintenance processes and procedures.
- Predictive Maintenance & Risk Minimisation: Oversee and improve the maintenance of property, plant and equipment across the manufacturing facility; develop and implement planned preventative and predictive maintenance strategies to improve equipment reliability and reduce production downtime; manage preventive maintenance schedules and coordinate the response to unplanned equipment failures.
- Shutdowns & Project Delivery: Project-manage shutdown periods for bioreactors and other production equipment, including upgrades and specialist works, using these to drive improvements to maintenance processes and asset reliability.
- Supplier & Contractor Oversight: Manage relationships with, coordinate and supervise external contractors, service technicians and suppliers for specialist works, ensuring alignment with operational objectives and continuous improvement.
- Safety & High-Risk Work Management: Oversee and maintain safe systems of work, including Lock Out Tag Out (LOTO) procedures and the management of high-risk activities (steam, heights, chemicals), ensuring team and contractor compliance with workplace health and safety requirements.
- GMP Compliance & Process Documentation: Ensure compliance with GMP standards and workplace health and safety requirements; develop and improve standard operating procedures (SOPs), maintenance documentation and operational systems; and maintain critical spares inventory and accurate records to support operational excellence.
- Technology & Systems Implementation: Leverage and improve digital tools and operational systems,



including computerised maintenance management systems (CMMS) and operational dashboards, to track equipment performance, prioritise maintenance and continuously enhance reliability and process efficiency.

Company Overview

Federated Biologics Pty Ltd is a biologics manufacturing company based in Alexandria, Sydney. The company designs, builds, and operates manufacturing facilities for the production of biologics.

The Role

The Operations Engineer (Process Improvement) is responsible for the reliability and continuous improvement of the company's manufacturing facility, utility systems and equipment. The role focuses on reviewing maintenance workflows and processes to identify inefficiencies and areas for improvement, and on overseeing and improving how maintenance is planned, delivered and documented.

Combining preventative maintenance strategy, data analysis and continuous improvement with the coordination of shutdowns, upgrades and external contractors, the role enhances operational efficiency, reduces downtime and maintains GMP compliance. You will work closely with process engineers, automation engineers and production teams, using your technical and analytical know-how, strong communication and ruthless prioritisation to keep manufacturing running safely and efficiently.

Key Responsibilities

- Process Improvement & Efficiency: Review maintenance workflows, processes and operational systems to identify inefficiencies and areas for improvement, and drive continuous improvement initiatives across plant and equipment to reduce failure rates, extend asset life, enhance operational efficiency and reduce costs.
- Data-Driven Decision-Making: Analyse equipment, maintenance and performance data to identify reliability issues and trends, and make recommendations to improve maintenance processes and procedures.
- Predictive Maintenance & Risk Minimisation: Oversee and improve the maintenance of property, plant and equipment across the manufacturing facility; develop and implement planned preventative and predictive maintenance strategies to improve equipment reliability and reduce production downtime; manage preventive maintenance schedules and coordinate the response to unplanned equipment failures.
- Shutdowns & Project Delivery: Project-manage shutdown periods for bioreactors and other production equipment, including upgrades and specialist works, using these to drive improvements to maintenance processes and asset reliability.
- Supplier & Contractor Oversight: Manage relationships with, coordinate and supervise external contractors, service technicians and suppliers for specialist works, ensuring alignment with operational objectives and continuous improvement.
- Safety & High-Risk Work Management: Oversee and maintain protected systems of work, including Lock Out Tag Out (LOTO)



procedures and the management of high-risk activities (steam, heights, chemicals), ensuring team and contractor compliance with workplace health and safety requirements.
- GMP Compliance & Process Documentation: Ensure compliance with GMP standards and workplace health and safety requirements; develop and improve standard operating procedures (SOPs), maintenance documentation and operational systems; and maintain critical spares inventory and accurate records to support operational excellence.
- Technology & Systems Implementation: Leverage and improve digital tools and operational systems, including computerised maintenance management systems (CMMS) and operational dashboards, to track equipment performance, prioritise maintenance and continuously enhance reliability and process efficiency.

Experience and Skills

- Technical Proficiency: Engineering or trade qualification in a relevant discipline (mechanical, electrical or similar), or equivalent professional experience in industrial maintenance.
- Maintenance & Reliability Experience: Demonstrated experience in maintenance and reliability engineering within a manufacturing, pharmaceutical or similarly regulated environment, including reviewing and improving maintenance processes and systems.
- Project Leadership: Experience project-managing equipment shutdowns, upgrades and contractor coordination in a production environment, working with cross-functional teams to implement process and equipment improvements.
- Analytical & Problem-Solving Mindset: Strong diagnostic and problem-solving capability across mechanical, electrical and utility systems; proven ability to assess systems and processes, identify inefficiencies and implement improvements.
- Technical Systems Knowledge: Demonstrated knowledge of utility systems including steam, water treatment, compressed gases and trade waste; familiarity with LOTO and high-risk work management (steam, heights, chemicals).
- Exceptional Communication: Facilitates open dialogue and collaboration across teams; combines analytical skills with clear documentation to assess procedures and translate insights into actionable recommendations.
- SOP Writing & Process Documentation: Experience creating and improving standard operating procedures, workflows and maintenance documentation to enhance reliability, efficiency and compliance.
- Compliance: Understanding of GMP or equivalent regulated-manufacturing compliance standards.

Nice to have

- Experience using a computerised maintenance management system (CMMS).
- Experience with bioprocessing equipment (e.g. bioreactors, fermenters, pumps, filters, centrifuges) and upstream bioprocessing.
- Experience with plant and utility equipment (e.g. compressed/specialty gases, steam boilers, water treatment / reverse osmosis, pumps).
- Experience in biologics, pharmaceutical or biotechnology manufacturing environments.
- Relevant workplace health and safety certifications.

Conditions of Employment

- This position is based on-site at the company’s manufacturing facility in Alexandria, NSW
- The successful candidate must be eligible to work in Australia or be willing to obtain appropriate work authorisation

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📌 Operations Engineer (Process Improvement) (New South Wales)
🏢 Federated Biologics
📍 New South Wales