Computerized System Validation (Csv) Site Lead

Csl Behring; Melbourne; Presencial; AUD 180 000 - 240 000; Tempo integral

Resumo da oferta

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

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

GAMP5

Annex 11

21 CFR Part 11

SDLC

Data integrity

Regulatory understanding

Formação académica

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

Ferramentas

PCS

MES

SCADA

Historians

IQ/OQ/PQ documentation

Descrição da oferta de emprego

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.

We are recruiting a Computerized System Validation (CSV) Site Lead to join our team at our manufacturing facility at 189–209 Camp Road, Broadmeadows, VIC 3047.

Job Description

CSL is seeking an experienced CSV Site Lead to own and govern Computerized System Validation (CSV) approach and strategy for site Operational Technology (OT) platforms supporting Manufacturing and QC Laboratories.

This is a senior individual contributor role with strong influence across site teams and external partners. Operating within a partner-led delivery model, the CSV Site Lead ensures OT systems remain in a validated state across their lifecycle and meet global CSV, quality, data integrity, and regulatory expectations.

You will act as the site CSV authority for OT Platforms, providing strategic direction, governance, and oversight across CSV planning, delivery, vendor QMS integration, and driving regulatory inspections and inspection readiness.

This is a Permanent full-time position.

Key Responsibilities

• Own and govern the site CSV strategy for OT platforms (Manufacturing and Labs), ensuring alignment with global standards and a risk-based GAMP5 approach across SOPs, templates, tools, and methodologies.
• Lead CSV delivery through external partners, including planning, resourcing, prioritisation, performance oversight, and vendor/QMS governance with review and approval of key CSV deliverables.
• Ensure that the validated state of OT systems are established and maintained throughout their lifecycle, overseeing upgrades, patches, configuration changes, integrations, change control, impact assessments, deviations, and CAPAs.
• Act as the site CSV subject matter expert for OT Systems, driving and supporting regulatory inspections, internal audits, inspection readiness, and remediation activities.
• Partner cross-functionally and build site capability, collaborating with Automation, Manufacturing, QC, Quality, IT, and Global CSV teams.
• Provide coaching and training, as well as driving continuous improvement initiatives.

Qualifications & Experience

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

Application Period: Applications open on 16 October and close on 16 Novemmber 2026.