Process Engineer Consultant - Commissioning & Qualification (C&Q;)
Melbourne's Northern Suburbs | Immediate pipeline for November **** start
Hourly rate: $63 - $78/hr + 12% Super, depending on experience
Start: From November ****, with hiring continuing into early ****
Duration: Minimum 12 months, with extensions likely through associated site shutdowns in *********
Location: Melbourne's Northern suburbs (one of Australia's largest global manufacturing sites)
Working arrangement: Fully on-site; occasional WFH only where required, not scheduled
Peritus Consulting Partners is seeking
Process Engineer Consultants
to join the Process Specialist & Manufacturing Team of a global biotherapeutics manufacturer, supporting a major process integration project. Reporting to the Commissioning & Qualification (C&Q;) Lead, these positions are pivotal in integrating new process technology into the facility and ensuring manufacturing staff meet key project timelines and objectives, working alongside local and global counterparts across Manufacturing, Project Delivery, Quality and Regulatory Affairs.
Key Responsibilities
Execute risk-based qualification in compliance with company standards and regulatory guidelines
Commission and qualify systems (equipment, utilities, facilities and processes)



used to manufacture products in a GMP workplace
Develop documentation for qualification/verification procedures and technical reports
Prepare Project/Qualification plans, protocols and reports on completed studies
Support the creation of master plans, SOPs and work instructions aligned to global and site‐specific procedures and regulatory requirements
Work alongside validation contractors and project teams to achieve project deliverables
Essential Skills & Experience
Engineering degree (Biotech, Pharmaceutical, Mechanical or Chemical) or Science degree (Biotech, Chemical, Pharmaceutical)
Experience within a Commissioning and Qualification/Project function in biotech, pharma, medical devices manufacturing or another regulated manufacturing industry
Strong verbal and written communication skills, with the ability to present to audiences at all levels within an organisation
Excellent time management skills, with the flexibility to manage changing priorities and multiple tasks
Knowledge of industry guidance documents and standards, with a good understanding of validation and qualification principles
Desirable
Functional knowledge of cGMPs and manufacturing operations in an FDA‐regulated facility
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📌 Process Engineer (Melbourne)
🏢 Peritus Recruitment
📍 Melbourne