Process Engineer

2 days ago

melbourne, victoria, Australia PSC Biotech Full-time

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 docume