About this role
C&Q Engineer
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.
Location
Apply Now
Related jobs
Senior C&Q Principal Broadmeadows, AUSTRALIA
C&Q Principal Broadmeadows, AUSTRALIA
Electrical & Instrumentation (E&I) Maintenance Engineer Broadmeadows, AUSTRALIA
Process Engineer - Utilities Broadmeadows, AUSTRALIA
Share this job