We are looking for a Process Engineer - Utilities to join our team on a 12-month contract. Work alongside a talented PSC Biotech Team in an exciting, developing, and diverse biotechnology landscape.

The role is also responsible and accountable for supporting the PSC mission: “to maintain the integrity and professionalism of our products and services while enabling steady growth and development.”

Key Duties and Responsibilities

- Support process engineering activities for recent, modified, and existing utility and manufacturing systems across the project lifecycle.

- Support the design, installation, startup, commissioning, qualification, and optimisation of utility systems and associated process equipment.

- Prepare, review, revise, and complete controlled engineering and CQV documentation, including specifications, drawings, risk assessments, test protocols, reports, procedures, and turnover records.

- Execute and document DQ, FAT, SAT, IQ, OQ, PQ, and other commissioning or validation activities, as applicable to the assigned systems and project scope.

- Perform field verification, system walkdowns, inspections, testing, troubleshooting, and readiness checks for utilities, equipment, instruments, controls, and interfaces.

- Assess utility capacity, performance, reliability, and compliance against process requirements, user requirements, design intent, and operational needs.

- Support process startup and the introduction of new or modified equipment and systems into GMP operations.

- Provide process engineering input into technical specifications, equipment selection, P&IDs;, layouts, control strategies, operating parameters, and system boundaries.

- Assist with technology transfer, process scale-up, equipment readiness, and the development or revision of SOPs and operating documentation.

- Troubleshoot process and utility issues, identify root causes, and recommend practical improvements that strengthen safety, compliance, reliability, and performance.
- Collaborate with client teams, quality,



operations, maintenance, automation, vendors, and contractors to deliver project milestones and resolve technical issues.

- Provide clear progress updates, escalate risks or constraints promptly, and complete assigned deliverables within agreed timelines.
- Work safely and comply with PSC and client policies, procedures, permit requirements, and site safety expectations.

- Additional duties and responsibilities may be assigned from time to time.

Utilities Experience

- Experience supporting one or more of the following is desirable, depending on the project scope:
- Clean and process utilities, such as purified water, water for injection, clean steam, process gases, compressed air, and clean-in-place systems.
- Plant utilities, such as HVAC, chilled water, cooling water, glycol, steam, condensate, electrical interfaces, and waste systems.
- Process equipment, including vessels, pumps, valves, heat exchangers, piping, instrumentation, automated skids, and associated control systems.
- Aseptic, controlled, or highly automated manufacturing environments.

Requirements

- Bachelor Degree in Engineering, Science, or a related discipline.
- At least 2 years of relevant engineering experience within pharmaceutical, biotechnology, medical device, or another regulated GMP environment.

- Practical experience supporting process development, utilities, equipment startup, commissioning, qualification, validation, or manufacturing operations.

- Experience preparing, reviewing, or executing engineering and CQV documentation, such as specifications, risk assessments, FAT, SAT, IQ, OQ, PQ, protocols, and reports.

- Working knowledge of GMP, GDP, data integrity, quality systems, and regulated project delivery expectations.

- Ability to read and interpret technical drawings, P&IDs;, specifications, manuals, and vendor documentation.

- Strong analytical, troubleshooting, organisation, and written communication skills.

- Ability to work collaboratively across disciplines and manage competing priorities in a project environment.

📌 Process Engineer - Utilities (Melbourne)
🏢 PSC Biotech
📍 Melbourne