Utilities Engineer

POSITION SUMMARY

The Utilities Engineer is responsible for ensuring the reliable, safe, and efficient operation of all utility systems supporting pharmaceutical manufacturing processes. These systems include (but are not limited to) purified water, clean steam, plant steam, HVAC, compressed air, waste treatment, and other critical infrastructure. The Utilities Engineer plays a key role in maintaining compliance with regulatory requirements (e.g., FDA, GMP, TGA, APVMA and Australian Standards), supporting production, and driving continuous improvement in utility system performance.

POSITION RESPONSIBILITIES

Operation & Maintenance

· Oversee daily operation, troubleshooting, and maintenance of utility systems (e.g., water purification, clean steam, plant steam, HVAC, compressed gases, chilled water, waste treatment).

· Develop and implement preventive and predictive maintenance programs for all utilities (central and satellite).

· Respond promptly to utility system alarms, failures, or deviations.

· Supervise external service providers and contractors to ensure work is completed safely, efficiently, and in compliance with regulatory and site requirements.

Compliance & Documentation

· Ensure all utility systems meet applicable regulatory standards (TGA, APVMA, Australian Standards, FDA, GMP, EH&S).

· Maintain accurate records of system performance, maintenance, calibrations, and deviations using SAP PM (Plant Maintenance) and TrackWise ETS (Deviations & Change Control).

· Support validation, qualification, and periodic review of utility systems.

Project Support

· Participate in utility system upgrades, expansions, and new installations.

· Collaborate with project teams, contractors, and vendors to ensure utility projects are delivered on time and within budget and in compliance with relevant Australian Standards and regulatory requirements.

Continuous Improvement

· Identify opportunities to improve reliability, efficiency, and sustainability of utility systems.

· Lead or support root cause analysis and corrective actions for utility-related issues.

· Stay current with emerging technologies and best practices in utility engineering.

Safety & Training

· Promote a culture of safety and compliance within the utilities engineering team.

· Provide training and technical support to operations and maintenance staff.

ORGANIZATIONAL RELATIONSHIPS

· Reports to site Engineering Manager.

· Interaction with quality assurance, finance, manufactuiring and site leadership teams.

· Collaboration with external vendors and service providers for utilities system maintenance.

· Interaction with Global Engineering and Local Engineering team.

EDUCATION AND EXPERIENCE

Education

· Bachelor’s degree in Mechanical, Chemical, Electrical Engineering, or related discipline.

Experience

· 3+ years of experience in utilities engineering, preferably in pharmaceutical or regulated manufacturing environments.

· Hands-on experience with, including operation, maintenance, and troubleshooting of gas-fired boilers and steam distribution networks.

· Hands-on experience with plant steam systems, purified water systems (WFI, RO, DI), clean steam, HVAC (including cleanroom environments), compressed air, and waste treatment.

· Experience with Siemens PCS7 and its application in pharmaceutical manufacturing.

· Experience in capital projects delivery, in particular commmssioning & qualification .

· Experience in Large Scale Bioengineering/Process Engineering (preferred).

· Experience in highly regulated GMP, EHS and Biosecurity pharmaceutical and biotechnology facilities, equipment and operations (desirable).

TECHNICAL SKILLS REQUIREMENTS

· Strong knowledge of TGA (Therapeutic Goods Administration), APVMA (Australian Pesticides and Veterinary Medicines Authority) regulations, and relevant Australian Standards.

· Strong knowledge of GMP, FDA, and EH&S regulations.

· Proficiency in problem-solving, troubleshooting, root cause analysis, and technical report writing.

· Experience with SAP PM (Plant Maintenance) for scheduling, tracking, and documenting maintenance activities.

· Excellent communication and teamwork skills.

· Strong understanding of GMP standards and regulatory requirements for pharmaceutical manufacturing.

· Strong communication and documentation skills.

· Effective leadership skills and experience working in cross-functional teams.

· Organizational skills, dependability, and the ability to work as part of a team are essential.

· Strong commitment to service and quality.

· Ability to navigate & operate virtual meetings in various platforms.

· Proficient in English, both oral and written, with sound technical writing skills.

PHYSICAL POSITION/QUALIFICATION REQUIREMENTS

· Ability to work in manufacturing and utility areas (including confined spaces, elevated platforms, noisy environments, GMP facility with climate & environmentally controlled with clean and classified area).

· Wear various manufacturing suits dependent on the production activities being performed. The attires include:

o Lab coat, steel-capped safety boots, hairnet, beard snood (where applicable), and safety glasses (where signposted)

o Primary gowning (for controlled area work)

o Secondary gowning consisting of sterile gown, boots, mask, gloves and safety glasses/ googles (for aseptic operations)

o No special clothing requirements for all office based activities (street clothes only).

· Occasional lifting, climbing, and working with tools or machinery.

· On-call or shift work may be required (future).

· On site presence. Working from home can be permitted on unfrequent ad-hoc basis and prior approval. The roles requires the ability to work flexible hours as needed.

· Tetanus and Covid-19 vaccination. Other vaccinations might be required in the future.

NOTE: Completion of Federal Police Check, Politically Motivated Violence Checks or other checks as required by Biosecurity legislation.