Commissioning & Qualification Engineer

About the role

The Commissioning & Qualification Engineer will join a global biopharmaceutical leader at its Broadmeadows site. Reporting to the C&Q Senior Principal, you will plan, develop and execute commissioning and qualification activities for automated pharmaceutical processing equipment, ensuring compliance with GxP and regulatory standards.

Key responsibilities

• Plan, coordinate and manage qualification activities for automated pharmaceutical processing equipment.
• Generate test scripts, protocols and qualification documentation.
• Execute qualification testing on site, including FAT, SAT, DQ, IV and OV activities.
• Review and contribute to GxP documentation such as URS, risk assessments and change controls.
• Translate C&Q plans into detailed test plans for assigned systems and process areas.
• Collaborate with Process Engineering, Project Delivery, Validation, R&D, QC and other stakeholders.
• Interpret technical drawings, engineering documents and process information.
• Identify issues, ask critical questions and support compliant project delivery.

Required profile

• Relevant tertiary qualification in Science or Engineering (Chemical, Mechanical or Bioprocess preferred).
• 5+ years’ experience in commissioning and qualification within a GMP‑regulated environment.
• Strong understanding of pharmaceutical processing equipment and qualification requirements.

Required skills

• Commissioning & Qualification
• Factory Acceptance Test (FAT)
• Site Acceptance Test (SAT)
• Design Qualification (DQ)
• Installation Qualification (IV)
• Operational Qualification (OV)
• GxP compliance
• Validation principles
• Risk assessment
• User Requirements Specification (URS)
• Change control
• Technical drawing interpretation