Process Engineer - Utilities

PSC Biotech® Corporation; City of Melbourne; On-site; AUD 90,000 - 130,000; Full time

Job summary

PSC Biotech Corporation is seeking a Process Engineer - Utilities to join our Melbourne team on a 12-month contract, focusing on supporting utility and manufacturing systems through the project lifecycle.

You will design, install, start up, qualify and optimise utility systems, collaborate with cross-functional teams, and ensure CQV documentation and GMP compliance throughout project milestones. This role offers valuable exposure to a developing biotechnological landscape.

Qualifications

• Bachelor’s degree in engineering or related discipline.
• Experience in process development and utilities
• Familiarity with CQV documentation (specifications, risk assessments, test protocols).
• Experience in GMP environments and regulated project delivery.
• Ability to read/interpret P&IDs and technical drawings.
• Strong analytical and problem-solving skills.

Responsibilities

• Support process engineering for utility and manufacturing systems across the project lifecycle.
• Design, install, start up, commission, qualify and optimise utility systems and equipment.
• Prepare, review and complete CQV documentation and turnover records.
• Execute DQ, FAT, SAT, IQ, OQ, PQ and other commissioning activities.
• Perform field verification, inspections, testing, and readiness checks for utilities and interfaces.
• Assess utility capacity, performance, reliability and compliance with requirements.
• Support startup and introduction of new or modified equipment into GMP operations.
• Provide input into specifications, layouts, control strategies, and operating parameters.
• Assist with technology transfer, scale-up, SOPs, and operating documentation.
• Troubleshoot issues and drive safety, compliance, reliability improvements.
• Collaborate with client teams, quality, operations, maintenance, automation, vendors and contractors.

Skills

Process engineering

CQV documentation

GMP familiarity

Education

Bachelor’s Degree in Engineering

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, 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.
  

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, 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.