Senior Computer System Validation (CSV) Engineer

CAI; Melbourne; Presencial; AUD 110.000 - 150.000; Jornada completa

Descripción de la vacante

CAI is seeking a hands-on CSV Specialist to join a cutting-edge advanced therapeutics facility in Australia. The role focuses on leading IQ/OQ/PQ activities within GxP systems, ensuring regulatory compliance, and coordinating with IT, QC and business teams to meet data integrity and validation needs.

You will author validation plans, risk assessments and traceability matrices, while training staff and supporting audits in a high-growth, high-integrity environment. Sydney location.

Formación

• 3+ years’ experience in CSV in pharma, biotech, or medical devices.
• Strong knowledge of GAMP 5, data integrity, and relevant regulatory frameworks.
• Experience validating ERP, LIMS, QMS, or equipment-related software.
• Detail-oriented, analytical, and proactive team player.
• Comfortable working flexibly to meet production schedules.
• Australia/New Zealand PR or Citizen

Responsabilidades

• Lead validation activities (IQ/OQ/PQ) across GxP-regulated systems.
• Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5.
• Partner with IT, QC, and business teams to meet user and regulatory needs.
• Author and review validation plans, risk assessments, and traceability matrices.
• Contribute to data integrity programs and support audits. Train staff and promote a quality-focused culture.

Conocimientos

CSV experience

GxP knowledge

Data integrity

Regulatory awareness

Detail-oriented

Analytical

Team player

Flexible scheduling

Herramientas

ERP

LIMS

QMS

Descripción del empleo

CAI Overview

Are You Ready?

CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For Life Sciences and Mission Critical industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach, field-tested processes, and elite expertise developed over 30 years.

Our approach is simple because our Purpose informs everything we do

• We exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience.

At CAI, we are committed to living our Foundational Principles, both professionally and personally

• We act with integrity
• We serve each other
• We serve society
• We work for our future

At CAI, we believe in a relentless dedication to excellence, pushing boundaries and surpassing expectations. From the beginning, we’ve challenged ourselves to do what others wouldn’t. Not just setting industry standards, but redefining them entirely. We are bold in our thinking and creative in our approach. We operate at the intersection of wisdom and technology and thrive when they come together with humanity. For us, operational readiness isn’t simply a goal. It’s a way of life. Because tomorrow demands to be at the forefront of today. We do this through tireless effort, precision, efficiency and an unwavering belief that there is always room for advancement. We’re not interested in how it used to be done. We’re obsessed with how it will be done.

About the Role

We are seeking a hands-on, experienced Computer System Validation (CSV) Specialist to join a cutting-edge advanced therapeutics facility based in Australia’s largest health, education, research, and innovation precinct.

This full-time opportunity is ideal for someone with a strong background in CSV within GxP environments, looking to make a meaningful impact in a high-growth, high-integrity setting.

Work Location: Sydney, Australia

Employment Type: Full Time Employee

Requirements include:

• 3+ years’ experience in CSV in pharma, biotech, or medical devices.
• Strong knowledge of GAMP 5, data integrity, and relevant regulatory frameworks.
• Experience validating ERP, LIMS, QMS, or equipment-related software.
• Detail-oriented, analytical, and proactive team player.
• Comfortable working flexibly to meet production schedules.
• Australia/New Zealand PR or Citizen

Position Requirements:

• Lead validation activities (IQ/OQ/PQ) across GxP-regulated systems.
• Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5.
• Partner with IT, QC, and business teams to meet user and regulatory needs.
• Author and review validation plans, risk assessments, and traceability matrices.
• Contribute to data integrity programs and support audits. Train staff and promote a quality-focused culture.

Why Join?

You’ll join a values-driven team pushing the boundaries in therapeutic manufacturing — with plenty of room to grow, innovate, and shape the future of health.

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