CSV Site Lead - OT Validation for Manufacturing & Labs

Csl Behring; Melbourne; Vor Ort; AUD 180.000 - 240.000; Vollzeit

Zusammenfassung

CSL Behring in Broadmeadows, VIC, is seeking an experienced CSV Site Lead to own and govern Computerized System Validation for OT platforms across manufacturing and QC labs. This senior role provides strategic direction, governance, and oversight of CSV planning, vendor QMS integration, and readiness for regulatory inspections.

You will work across Automation, Manufacturing, Quality and IT teams, coaching staff and external partners to maintain validated state, drive risk-based improvements, and

Qualifikationen

• 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.
• Hands-on validation of OT and execution systems (PCS, MES, SCADA, Historians, lab systems).
• Experience authoring CSV documentation (IQ/OQ/PQ) and vendor-based delivery.

Aufgaben

• Own and govern the site CSV strategy for OT platforms.
• Lead CSV delivery through external partners with governance on deliverables.
• Maintain validated state across lifecycle including changes and CAPAs.
• Act as CSV SME for OT Systems, supporting inspections and audits.
• Collaborate with Automation, Manufacturing, QC, Quality, IT, and Global CSV teams.
• Provide coaching and drive continuous improvement.

Kenntnisse

GAMP5

Annex 11

21 CFR Part 11

SDLC

Data integrity

Regulatory understanding

Ausbildung

Bachelor’s degree in Engineering, Automation, Computer Science, or equivalent

Tools

PCS

MES

SCADA

Historians

IQ/OQ/PQ documentation

Jobbeschreibung

CSL Behring in Broadmeadows, VIC, is seeking an experienced CSV Site Lead to own and govern Computerized System Validation for OT platforms across manufacturing and QC labs. This senior role provides strategic direction, governance, and oversight of CSV planning, vendor QMS integration, and readiness for regulatory inspections.

You will work across Automation, Manufacturing, Quality and IT teams, coaching staff and external partners to maintain validated state, drive risk-based improvements, and