Process Engineer - Utilities

biotech; City of Melbourne; On-site; AUD 90,000 - 120,000; Full time

Job summary

PSC Biotech is seeking a Process Engineer - Utilities for a 12-month contract in Melbourne, Australia. The role focuses on supporting utility and manufacturing systems across the project lifecycle, including CQV documentation and commissioning activities.

The ideal candidate will have a Bachelor degree in Engineering or Science and at least 2 years of relevant GMP experience, with strong analytical, troubleshooting, and documentation skills.

Qualifications

• Bachelor degree in Engineering, Science, or a related discipline.
• Strong analytical and troubleshooting skills and ability to document results clearly.
• Ability to read and interpret technical drawings, P&IDs, specifications, and vendor documentation.
• Experience working in GMP, GDP, and regulated project delivery environments.
• Excellent written and verbal communication skills and ability to manage multiple priorities.

Responsibilities

• Support process engineering activities for utility and manufacturing systems across the project lifecycle.
• Assist design, installation, startup, commissioning, qualification, and optimisation of utility systems and equipment.
• Prepare and review CQV documentation including specifications, drawings, risk assessments, test protocols, and turnover records.
• Execute commissioning/validation activities (DQ, FAT, IQ, OQ, PQ) as applicable to the project.
• Perform field verification, inspections, testing, troubleshooting, and readiness checks for utilities and interfaces.
• Collaborate with client teams, quality, operations, maintenance, automation, vendors, and contractors to meet milestones.
• Provide progress updates and raise risks promptly to meet timelines.
• Work safely and comply with policies, permits, and site safety expectations.

Skills

Analytical thinking

Troubleshooting

Documentation

Cross-disciplinary collaboration

Reading technical drawings

Education

Bachelor degree in Engineering or Science

Job description

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 new, 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, escape 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.