GMP Commissioning & Qualification Engineer

CSL Limited; Melbourne; On-site; AUD 110,000 - 160,000; Full time

Job summary

CSL Behring is recruiting a Commissioning & Qualification Engineer to support and execute commissioning, qualification, and maintenance of manufacturing systems in a GMP environment at Broadmeadows, VIC. You will work with Process Engineering, Validation, Quality, and Manufacturing to deliver compliant projects.

The role includes preparing protocols, maintaining documentation, and supporting training and HS&E risk assessments within a dynamic, regulated facility.

Qualifications

• Tertiary qualification in Science or Engineering required or equivalent commissioning/qualification experience.
• Strong written and verbal communication with cross-functional engagement in GMP environments.

Responsibilities

• Execute commissioning and qualification activities for facilities, equipment, utilities, and systems within a GMP environment.
• Prepare, review, and maintain qualification/commissioning protocols, reports, and documentation for regulatory compliance.
• Manage document control activities, including DMS maintenance and departmental documentation.
• Maintain qualification and commissioning test equipment and ensure readiness for audits.
• Collaborate with Engineering, Project Delivery, Validation, Quality, R&D, QC, and Manufacturing to deliver projects.

Skills

Communication skills

Cross-functional collaboration

Problem solving

Education

Tertiary qualification in Science or Engineering

Tools

DMS

Microsoft Office

Job description

CSL Behring is recruiting a Commissioning & Qualification Engineer to support and execute commissioning, qualification, and maintenance of manufacturing systems in a GMP environment at Broadmeadows, VIC. You will work with Process Engineering, Validation, Quality, and Manufacturing to deliver compliant projects.

The role includes preparing protocols, maintaining documentation, and supporting training and HS&E risk assessments within a dynamic, regulated facility.