Senior Computer System Validation (CSV) Engineer

Caiready; Sydney; Híbrido; AUD 90 000 - 130 000; Tempo integral

Resumo da oferta

CAI is seeking a hands-on CSV Specialist to join a cutting-edge advanced therapeutics facility in Sydney, Australia. This full-time role focuses on validation activities within GxP environments, delivering compliant, high-integrity systems and processes.

You will lead IQ/OQ/PQ across ERP, LIMS, QMS, and equipment software, collaborate with IT, QC, and business teams, and contribute to data integrity programs while supporting audits and training staff for a quality-focused culture.

Qualificações

• 3+ years’ experience in CSV within 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.
• 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.

Conhecimentos

CSV validation

GxP

Regulatory knowledge

Data integrity

ERP validation

LIMS validation

Ferramentas

QMS software

ERP systems

LIMS software

Descrição da oferta de emprego

Melbourne/Australia/Full Time

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 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.