Job Description
Process Engineer Consultant - Commissioning & Qualification (C&Q;)
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Melbourne's Northern Suburbs | Immediate pipeline for November **** start
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Hourly rate: $63 - $78/hr + 12% Super, depending on experience
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Start: From November ****, with hiring continuing into early ****
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Duration: Minimum 12 months, with extensions likely through associated site shutdowns in *********
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Location: Melbourne's Northern suburbs (one of Australia's largest global manufacturing sites)
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Working arrangement: Fully in office; occasional WFH only where required, not scheduled
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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.
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Key Responsibilities
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Execute risk-based qualification in compliance with company standards and regulatory guidelines
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Commission and qualify systems (equipment, utilities, facilities and processes)



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