C&Q Engineer

CSL; Broadmeadows; On-site; AUD 120,000 - 170,000; Full time

Job summary

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

The role focuses on preparing and maintaining qualification documentation, managing DMS and test equipment, and ensuring adherence to cGMP and HSE policies while mentoring new team

Qualifications

• Degree in Science or Engineering or equivalent commissioning/qualification experience.
• Experience in a pharmaceutical manufacturing environment is highly desirable.
• Strong computer literacy and proficiency in Microsoft Office.
• Sound understanding of cGMP requirements and qualification principles.

Responsibilities

• Execute commissioning and qualification activities for facilities, equipment, utilities, and systems in a GMP environment.
• Prepare, review, and maintain qualification/commissioning protocols and reports for regulatory compliance.
• Manage document control activities and maintain departmental documentation.
• Maintain qualification and commissioning test equipment.
• Collaborate with cross-functional teams to ensure efficient project delivery.
• Ensure activities comply with CSL quality standards, cGMP, regulatory guidelines and HSE policies.
• Participate in problem-solving, investigations and continuous improvement initiatives.
• Support HS&E risk assessments and provide training to new team members.

Skills

Pharma manufacturing experience

MS Office proficiency

cGMP understanding

Strong communication

Problem-solving

Organised and adaptable

Education

Science or Engineering degree

Tools

Microsoft Office

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.

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 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.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.