Commissioning & Qualification (C&Q) Lead

Your role

CSL Behring Australia is undergoing extensive and positive change as we expand and grow. In addition to contributing to Australia's export economy, CSL has invested and continues to invest in substantial new manufacturing facilities to support CSL's global strategy and provide the network with crucial supply of finished / intermediates sourced from our Australian facilities.

Due to an internal move, a position is available for a Commissioning & Qualification (C&Q) Lead to join our team at CSL Behring, Broadmeadows. Reporting to the Head of Project Engineering you will provide strategic, technical and people leadership for an integrated site C&Q function responsible for both project commissioning and qualification activities and ongoing lifecycle requalification programs.

Your responsibilities

Leading a Team Of Approximately 25 Engineering Professionals, You Will Be Accountable For Defining And Implementing The Site's C&Q Strategy, Ensuring Facilities, Utilities, Equipment And Processes Are Commissioned, Qualified And Maintained In a Compliant State Throughout Their Lifecycle. Specifically, You Will

• Lead the evolution of CSL’s C&Q model and create a hybrid delivery model leveraging engineering organisations to provide industry best practice, additional resource support and scalable solutions
• Lead, coach and develop a high-performing site C&Q organisation, fostering accountability, collaboration, technical excellence and continuous improvement
• Act as the senior C&Q Subject Matter Expert and ultimate responsibility for end-to-end C&Q delivery from design through commissioning, qualification, start-up, handover and ongoing lifecycle management
• Key interface between Engineering, Quality, Operations, Validation, Regulatory, Maintenance, external engineering partners and global C&Q / validation functions
• Accountable for embedding of digitally enabled C&Q practices, including adoption of ASTM E2500 principles, use of standard methods and templates, leveraging vendor documentation where appropriate, and effective use of digital validation platforms such as Kneat.

Your experience

To Be Successful In This Role You Possess

• Demonstrated experience leading commissioning, qualification, validation or lifecycle compliance activities in a cGMP environment
• Advanced knowledge of cGMP, TGA, FDA, PIC/S and relevant industry guidance for commissioning, qualification, validation and lifecycle compliance. Knowledge of ASTM E2500 principles is desirable
• Leadership experience in leading a function, change management and demonstrated history in delivery of hybrid work solutions
• Stakeholder engagement and influencing skills; ability to build credibility across technical teams, senior leadership and global functions
• A Bachelors degree in Engineering, Science or related discipline.

Apply now to manage a diverse and critical function in complex life sciences facilities! Please submit your application in one document.

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.