C&Q Engineer

Csl Behring; Melbourne; On-site; AUD 90,000 - 130,000; Full time

Job summary

CSL Behring in Broadmeadows, VIC is seeking a Commissioning & Qualification Engineer to support and execute qualification, commissioning, and maintenance of manufacturing systems within a GMP environment.

You will collaborate with Engineering, Validation, Quality, and Operations to deliver compliant projects, prepare protocols and documents, and maintain equipment and test rigs. This permanent full-time role emphasizes cGMP knowledge, problem solving, and mentoring junior staff.

Qualifications

• Tertiary qualification in Science or Engineering, or equivalent commissioning/qualification experience.
• Experience in pharmaceutical manufacturing is highly desirable, with strong computer literacy and proficiency in Microsoft Office.
• Sound understanding of cGMP requirements and commissioning/qualification principles.

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 supporting documentation for regulatory compliance.
• Manage document control activities, including DMS maintenance and departmental documentation.
• Collaborate with cross-functional teams to ensure efficient project delivery.
• Support HS&E risk assessments and provide training to team members.

Skills

Cross-functional collaboration

Microsoft Office

Strong communication

Problem solving

cGMP knowledge

Training and mentoring

Education

Science or Engineering degree

Tools

DMS (document management)

Job description

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.

We are recruiting a C&Q Engineer to join our team at 189–209 Camp Road, Broadmeadows, VIC 3047.

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.

This is a Permanent full-time position.

To be successful:

• Tertiary qualification in Science or Engineering, or equivalent commissioning/qualification experience.
• Experience within a pharmaceutical manufacturing environment 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.

Application Period: Applications open on 19th October and close on 19th November 2026.