Process Engineer - Utilities (Biotechnology)

Location: Melbourne, Australia

Company

hirify.global operates in a developing and diverse biotechnology landscape, supporting the integrity and professionalism of its products and services.

What you will do

• 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, and complete engineering and CQV documentation, including specifications, drawings, risk assessments, protocols, reports, procedures, and turnover records.
• Execute and document DQ, FAT, SAT, IQ, OQ, PQ, commissioning, and validation activities.
• Perform field verification, walkdowns, inspections, testing, troubleshooting, readiness checks, and utility capacity assessments.
• Collaborate with quality, operations, maintenance, automation, vendors, contractors, and client teams to deliver milestones and resolve technical issues.

Requirements

• Bachelor’s degree in engineering, science, or a related discipline.
• At least 2 years of relevant engineering experience in pharmaceutical, biotechnology, medical device, or another regulated GMP environment.
• Practical experience with process development, utilities, equipment startup, commissioning, qualification, validation, or manufacturing operations.
• Experience preparing, reviewing, or executing engineering and CQV documentation, including FAT, SAT, IQ, OQ, PQ, protocols, and reports.
• Working knowledge of GMP, GDP, data integrity, quality systems, technical drawings, P&IDs, specifications, and vendor documentation.
• Strong analytical, troubleshooting, organisational, written communication, collaboration, and prioritisation skills.

Nice to have

• Experience with clean and process utilities such as purified water, water for injection, clean steam, process gases, compressed air, and clean-in-place systems.
• Experience with plant utilities including HVAC, chilled water, cooling water, glycol, steam, condensate, electrical interfaces, and waste systems.
• Experience with process equipment, automated skids, instrumentation, control systems, or aseptic and highly automated manufacturing environments.

Culture & Benefits

• 12-month contract engagement.
• Work alongside a multidisciplinary hirify.global team in a biotechnology project environment.
• Support projects focused on safety, compliance, reliability, and operational performance.
• Follow PSC and client policies, procedures, permit requirements, and site safety expectations.