Project Engineer – GMP-CQV & Process Improvement

IDT Australia Limited; Melbourne; On-site; AUD 90,000 - 130,000; Full time

Job summary

IDT Australia in Boronia, Melbourne is seeking a Project Engineer to lead engineering projects, CQV activities and process improvements in a GMP environment. You will coordinate across Production, Quality and R&D teams from scoping through to handover, ensuring compliant, cost-effective outcomes.

The role emphasizes CQV execution, validation documentation and collaboration with internal stakeholders to enhance manufacturing capability, reliability and safety.

Qualifications

• Bachelor's degree in a relevant engineering discipline.
• Approximately 4 years' engineering experience in pharma or regulated manufacturing environments.
• Experience delivering engineering projects from planning and design through to commissioning and handover.
• Demonstrated CQV experience within GMP-regulated environments, including IQ/OQ/PQ protocols.

Responsibilities

• Coordinate engineering and capital projects from concept to commissioning and handover.
• Develop project scopes, URS, technical specifications, schedules, budgets and engineering documentation.
• Coordinate suppliers, contractors and internal stakeholders to deliver safe, compliant and cost-effective outcomes.
• Support process engineering activities, including manufacturing improvements, troubleshooting, trials and scale-up.
• Undertake commissioning, qualification and validation activities across equipment, facilities, utilities and related systems.
• Prepare, review and execute qualification protocols (DQ, IQ, OQ, PQ) and maintain validation documentation.
• Participate in engineering change controls, risk assessments and investigations.
• Identify opportunities to improve manufacturing efficiency, equipment performance, reliability and safety.
• Ensure engineering activities comply with GMP requirements, quality systems and safety obligations.

Skills

Project coordination

GMP knowledge

CQV experience

Communication skills

Problem-solving

Education

Bachelor's degree in Mechanical/Chemical/Process/Electrical Engineering

Job description

IDT Australia in Boronia, Melbourne is seeking a Project Engineer to lead engineering projects, CQV activities and process improvements in a GMP environment. You will coordinate across Production, Quality and R&D teams from scoping through to handover, ensuring compliant, cost-effective outcomes.

The role emphasizes CQV execution, validation documentation and collaboration with internal stakeholders to enhance manufacturing capability, reliability and safety.