The Opportunity:

The Commissioning & Qualification (C&Q;) Engineer is responsible for supporting and executing the commissioning, qualification, and maintenance of manufacturing systems and equipment within a regulated GMP environment. The role ensures that equipment, facilities, and processes are commissioned and qualified in accordance with CSL quality standards, regulatory requirements, and health, safety, and environmental guidelines.

The position plays a key role in the preparation, execution, and maintenance of qualification and commissioning activities, while working closely with cross-functional teams including Process Engineering, Project Delivery, Validation, Stability, Quality Control, Value Streams, R&D;, and Manufacturing Operations to deliver projects safely, efficiently, and compliantly.

The Role:

- Execute commissioning and qualification activities for facilities, equipment, utilities, and systems within a GMP-regulated environment.
- Prepare, review, and maintain qualification/commissioning protocols, reports, and supporting documentation to ensure regulatory compliance.
- Manage document control activities, including DMS maintenance and departmental documentation for operational and regulatory requirements.
- Maintain qualification and commissioning test equipment
- Collaborate with cross-functional teams including Engineering, Project Delivery, Validation, Quality, R&D;, QC,



and Manufacturing to ensure efficient project delivery.
- Ensure all activities are performed in accordance with CSL quality standards, cGMP requirements, regulatory guidelines, and HSE policies.
- Participate in problem-solving, investigations, and continuous improvement initiatives to optimise processes and systems.
- Support HS&E; risk assessments, maintain training compliance, and provide training and mentoring to new team members.

To be successful:

- Tertiary qualification in Science or Engineering, or equivalent commissioning/qualification experience.
- Experience within a pharmaceutical manufacturing workplace is highly desirable, with strong computer literacy and proficiency in Microsoft Office applications.
- Sound understanding of cGMP requirements, commissioning and qualification principles, and relevant industry standards and guidelines.
- Strong written, verbal, presentation, and interpersonal communication skills, with the ability to engage effectively with stakeholders.
- Demonstrated problem-solving, negotiation, and customer-focused mindset, with the ability to drive outcomes and continuous improvement.
- Highly organised and adaptable, with the ability to manage multiple priorities and deliver tasks within established timelines and project schedules.

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📌 C&Q Engineer (Melbourne)
🏢 CSL
📍 Melbourne