CSV Site Lead: OT Systems Validation & Compliance

CSL; Melbourne; On-site; AUD 150,000 - 190,000; Full time

Job summary

CSL Behring is seeking a Computerized System Validation (CSV) Site Lead for our Broadmeadows, VIC manufacturing facility. The role is a permanent full-time senior position owning the CSV approach for OT platforms supporting Manufacturing and QC Laboratories.

The Site Lead will govern CSV planning, vendor QMS integration, and drive regulatory inspections with a focus on data integrity and adherence to global CSV standards.

Qualifications

• Bachelor’s degree in Engineering, Automation, Computer Science, or equivalent.
• 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 (PCS, MES, SCADA, Historians, and lab systems).
• Proven ability to author, review, and approve CSV documentation (IQ/OQ/PQ) and manage vendor-based delivery models.
• Experience supporting regulatory inspections and audit readiness, with strong stakeholder engagement and governance.

Responsibilities

• Own and govern the site CSV strategy for OT platforms across manufacturing and labs.
• Lead CSV delivery through external partners, including planning and governance.
• Ensure OT systems remain validated across their lifecycle and manage changes.
• Act as site CSV SME for regulatory inspections, audits, and remediation activities.
• Collaborate with cross-functional teams (Automation, Manufacturing, QC, Quality, IT, Global CSV).
• Provide coaching, training, and drive continuous improvement initiatives.

Skills

CSV governance

Regulatory engagement

Stakeholder engagement

Vendor management

Quality systems

Education

Bachelor’s degree in Engineering/Automation/Computer Science

Tools

GAMP5

Annex 11

21 CFR Part 11

SDLC

Data integrity

Job description

CSL Behring is seeking a Computerized System Validation (CSV) Site Lead for our Broadmeadows, VIC manufacturing facility. The role is a permanent full-time senior position owning the CSV approach for OT platforms supporting Manufacturing and QC Laboratories.

The Site Lead will govern CSV planning, vendor QMS integration, and drive regulatory inspections with a focus on data integrity and adherence to global CSV standards.