Lead CSV delivery through external partners, including planning, resourcing, prioritisation, performance oversight, and vendor/QMS governance with review and approval of key CSV deliverables.
Ensure that the validated state of OT systems are established and maintained throughout their lifecycle, overseeing upgrades, patches, configuration changes, integrations, change control, impact assessments, deviations, and CAPAs.
Act as the site CSV subject matter expert for OT Systems, driving and supporting regulatory inspections, internal audits, inspection readiness, and remediation activities.
Partner cross-functionally and build site capability, collaborating with Automation, Manufacturing, QC, Quality, IT, and Global CSV teams.
Provide coaching and training, as well as driving continuous improvement initiatives.
Qualifications & Experience
Bachelor’s degree in Engineering, Automation, Computer Science, or equivalent, with 7+ years’ CSV experience in pharmaceutical, biotech, or similarly regulated industries.
Strong knowledge of GAMP5, Annex 11, 21 CFR Part 11, SDLC, and data integrity principles.
Hands-on experience validating OT and execution systems (e.g. PCS, MES, SCADA, Historians, and laboratory systems).
Proven ability to author, review, and approve CSV documentation (IQ/OQ/PQ) and manage vendor-based delivery models.
Demonstrated experience supporting regulatory inspections and audit readiness, with strong stakeholder engagement, governance, and strategic capability.
Application Period: Applications open on 16 October and close on 16 Novemmber 2026.
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.
