CSV Site Lead: OT Manufacturing & QC Validation

CSL; Broadmeadows; On-site; AUD 140,000 - 190,000; Full time

Job summary

CSL Behring in Broadmeadows, VIC is seeking a senior CSV Site Lead to own the approach for OT platform validation across manufacturing and QC labs. This role drives governance, strategic direction, and lifecycle validation to meet global CSV and regulatory expectations.

You will lead delivery with external partners, coordinate with IT, Automation, and Quality teams, and support inspections and readiness. This is a permanent, full-time position offering influence across site operations and

Qualifications

• Senior CSV expertise with governance across OT platforms
• Strong knowledge of GAMP5, Annex 11, 21 CFR Part 11, SDLC
• Experience validating OT and execution systems (PCS, MES, SCADA)
• Proven ability to author, review and approve CSV documentation (IQ/OQ/PQ)
• Experience supporting regulatory inspections and audit readiness

Responsibilities

• Own and govern the site CSV strategy for OT platforms, ensuring risk-based approach
• Lead CSV delivery through external partners with governance and approvals
• Ensure validated state across lifecycle, including upgrades and change control
• Act as CSV SME for OT systems and drive inspections readiness and remediation
• Partner with Automation, Manufacturing, QC, Quality, IT and Global CSV teams
• Provide coaching, training and drive continuous improvement

Skills

CSV governance

OT systems

Regulatory inspections

Vendor management

Coaching & training

Education

Bachelor’s degree in Engineering/Automation/CS

Tools

IQ/OQ/PQ docs

SCADA

MES

Job description

CSL Behring in Broadmeadows, VIC is seeking a senior CSV Site Lead to own the approach for OT platform validation across manufacturing and QC labs. This role drives governance, strategic direction, and lifecycle validation to meet global CSV and regulatory expectations.

You will lead delivery with external partners, coordinate with IT, Automation, and Quality teams, and support inspections and readiness. This is a permanent, full-time position offering influence across site operations and