Process Engineer

Peritus Recruitment; City of Melbourne; On-site; AUD 131,000 - 162,000; Full time

Benefits offered by this job

On-site work

12% Super

Job summary

Peritus Recruitment is seeking Process Engineer Consultants to join the Process Specialist & Manufacturing Team of a global biotherapeutics manufacturer in Melbourne. Roles focus on integrating new process technology, ensuring staff meet timelines, and coordinating with local and global teams across Manufacturing, Project Delivery, Quality and Regulatory Affairs.

The position emphasizes risk-based qualification, GMP systems commissioning, and documentation development for protocols and reports,

Qualifications

• Engineering or science degree in biotech/pharma or related field.
• Experience in a commissioning and qualification function in biotech, pharma, medical devices or regulated manufacturing.
• Strong written and verbal communication with ability to present to diverse audiences.
• Good time management and adaptability to changing priorities.
• Knowledge of validation/qualification principles and industry guidance.

Responsibilities

• Execute risk-based qualification in line with standards and regulatory guidelines.
• Commission and qualify systems, equipment, utilities, facilities and processes in GMP environment.
• Develop qualification/verification procedures and technical reports.
• Prepare project/qualification plans, protocols and final reports.
• Support master plans, SOPs and work instructions aligned to global/site procedures.
• Collaborate with validation contractors and project teams to meet deliverables.

Skills

Communication skills

Time management

Regulatory compliance knowledge

GMP knowledge

Biotech/pharma industry experience

Education

Engineering degree in Biotech/Pharma/Mechanical/Chemical

Science degree in Biotech/Chemical/Pharmaceutical

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