Senior CSV Site Lead – OT & Manufacturing Systems

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

Job summary

CSL Behring is seeking an experienced CSV Site Lead to own and govern the CSV approach for OT platforms at the Broadmeadows manufacturing facility in Victoria. This senior role operates within a partner-led model to ensure validated state across lifecycle and alignment with global CSV, quality and regulatory expectations.

You will lead strategy, governance, and delivery with external partners, drive inspections readiness, and collaborate with Automation, Manufacturing, QC, Quality, IT and Global

Qualifications

• Bachelor’s degree in Engineering, Automation, CS or equivalent.
• 7+ years’ CSV experience in pharma/biotech, regulated industries.
• Strong knowledge of GAMP5, Annex 11, 21 CFR Part 11, SDLC and data integrity.
• Hands-on experience validating OT and execution systems (e.g., PCS, MES, SCADA).
• Experience authoring IQ/OQ/PQ documentation and vendor-based delivery models.
• Proven track record supporting regulatory inspections and audit readiness.

Responsibilities

• Own and govern the site CSV strategy for OT platforms across Manufacturing and Labs.
• Lead CSV delivery with external partners, planning and governance.
• Ensure OT systems stay validated across lifecycle including upgrades and changes.
• Act as site CSV SME for OT systems, supporting inspections and remediation.
• Collaborate with Automation, Manufacturing, QC, IT, and Global CSV teams.
• Provide coaching, training and drive continuous improvement initiatives.

Skills

CSV leadership

GAMP5 knowledge

Regulatory inspections

OT validation

Vendor governance

Stakeholder engagement

Education

Bachelor's degree in Engineering/Automation/CS

Tools

PCS

MES

SCADA

Historians

Lab systems

Job description

CSL Behring is seeking an experienced CSV Site Lead to own and govern the CSV approach for OT platforms at the Broadmeadows manufacturing facility in Victoria. This senior role operates within a partner-led model to ensure validated state across lifecycle and alignment with global CSV, quality and regulatory expectations.

You will lead strategy, governance, and delivery with external partners, drive inspections readiness, and collaborate with Automation, Manufacturing, QC, Quality, IT and Global