CSV Site Lead: OT Systems Validation & Strategy

CSL Limited; Melbourne; On-site; AUD 180,000 - 240,000; Full time

Job summary

CSL Behring is recruiting a senior CSV Site Lead to own validation strategies for OT platforms across Manufacturing and QC Labs. You will govern CSV programs, partner with external vendors, and ensure lifecycle validation in alignment with global standards and regulatory expectations.

In this role you will drive inspections readiness, support internal audits, and collaborate with cross-functional teams to build site capability and continuous improvement.

Qualifications

• Bachelor’s degree in Engineering, Automation, or Computer Science.
• 7+ years CSV experience in pharma/regulated industries.
• Strong knowledge of GAMP5, Annex 11, and 21 CFR Part 11.
• Hands-on experience validating OT and lab systems.
• Proven ability to author and approve CSV documentation and manage vendor-based delivery.
• Experience supporting regulatory inspections and audit readiness.

Responsibilities

• Own and govern the site CSV strategy for OT platforms (Manufacturing and Labs) per global standards and a risk-based GAMP5 approach.
• Lead CSV delivery through external partners, including planning, resourcing, prioritisation, performance oversight, and vendor/QMS governance.
• Ensure validated state of OT systems across lifecycle, overseeing upgrades, changes, integrations, and CAPAs.
• Act as the site CSV SME for OT systems, driving regulatory inspections, audits, and readiness.
• Partner cross-functionally with Automation, Manufacturing, QC, Quality, IT, and Global CSV teams.
• Provide coaching and training, and drive continuous improvement initiatives.

Skills

CSV expertise

GAMP5

Annex 11/21 CFR Part 11

SDLC

Data integrity

OT systems validation

Vendor management

Regulatory inspections

Education

Bachelor’s degree in Engineering

Bachelor’s degree in Automation

Bachelor’s degree in Computer Science

equivalent

Job description

CSL Behring is recruiting a senior CSV Site Lead to own validation strategies for OT platforms across Manufacturing and QC Labs. You will govern CSV programs, partner with external vendors, and ensure lifecycle validation in alignment with global standards and regulatory expectations.

In this role you will drive inspections readiness, support internal audits, and collaborate with cross-functional teams to build site capability and continuous improvement.