Validation Lead
Entity: CSL Behring
Job Category: Engineering
Job Family: Project Delivery
Job Type: Full Time
Location: Broadmeadows, Victoria, Australia
Employer Reference: R-276184
Job Description
We are seeking an experienced Validation Lead to operate as both a Subject Matter Expert (SME) and people leader within our MS&T and Validation function. This role is critical in ensuring all manufacturing and cleaning processes remain in a compliant, validated state while building strong validation capability across the site.
You will lead a team of skilled MS&T/Validation SMEs, drive validation strategies across product life cycle activities, and act as the primary site contact for validation matters during regulatory inspections.
Key Responsibilities
Lead and execute process and cleaning validation activities across routine operations, changes, and capital projects, ensuring all manufacturing processes remain in a validated state.
Define, implement, and continuously improve site validation strategies, including risk‑based approaches for registrations, lifecycle activities, and regulatory compliance.
Act as the primary validation contact for regulatory inspections and audits, including oversight of validation documentation and responses.
Provide validation expertise for deviations, root cause investigations, CAPAs, and risk assessments, identifying and closing compliance gaps.
Lead, coach, and develop a team of MS&T/Validation SMEs, driving capability building, engagement, and a culture of continuous improvement.
Key Requirements
Degree in Engineering or a relevant scientific discipline (advanced degree preferred).
8+ years’ experience in pharmaceutical manufacturing, quality, or operations within a cGMP environment, including 3+ years in validation.
Strong expertise in biopharmaceutical validation, including biologicals, aseptic processing, and cleaning validation.
Solid knowledge of global regulatory requirements, validation standards, and Quality by Design / risk management principles.
Demonstrated people leadership capability, with experience leading technical teams in a fast‑paced manufacturing environment.
How to Apply
Please submit your application, including your CV, as a single document.
Applications for this role will close on 23 April.
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.