Computerized System Validation (CSV) Site Lead

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 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.

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 use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.