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Listed 8 weeks ago

Process Engineer - Utilities

PSC Biotech

BioTech
Location
Melbourne, VIC
Type
Full-time

About the role

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. 


Apply

via biotech.zohorecruit.com

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