Process Engineer

Peritus Recruitment; City of Melbourne; On-site; AUD 87,000 - 107,000; Full time

Job summary

Peritus Consulting Partners seeks Process Engineer Consultants for a major biotherapeutics project in Melbourne's Northern Suburbs. The role is fully on-site with limited work-from-home exceptions, commencing from November 2026 for a 12-month pipeline with extensions possible.

Responsibilities include qualifying and commissioning systems in a GMP setting, developing protocol/report documentation, and aligning plans with global and site procedures.

Qualifications

• Engineering or science degree in biotech, pharma, or related field.
• Experience in commissioning/qualification in regulated manufacturing.
• Strong written and verbal communication skills.
• Ability to manage multiple tasks and changing priorities.
• Knowledge of validation/qualification principles and guidelines.

Responsibilities

• Execute risk-based qualification in compliance with standards and guidelines.
• Commission and qualify systems, utilities, and processes for GMP manufacturing.
• Develop qualification/verification documentation and technical reports.
• Prepare project/qualification plans, protocols and study reports.
• Support master plans, SOPs, and work instructions aligned to procedures.
• Collaborate with validation contractors and project teams to meet deliverables.

Skills

Engineering degree

C&Q experience

Communication skills

Time management

Validation principles

Education

Engineering or Science degree

Job description

Process Engineer Consultant - Commissioning & Qualification (C&Q)

Melbourne's Northern Suburbs | Immediate pipeline for November 2026 start

• Hourly rate: $63 - $78/hr + 12% Super, depending on experience
• Start: From November 2026, with hiring continuing into early 2027
• Duration: Minimum 12 months, with extensions likely through associated site shutdowns in 2027-2028
• 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 environment
• 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