Senior CSV Engineer: Validation & Data Integrity Lead

Cagents; City of Melbourne; On-site; AUD 90,000 - 130,000; Full time

Job summary

CAI seeks a hands-on CSV Specialist to join a cutting-edge therapeutics facility in Australia’s largest health, education, research and innovation precinct. This full‑time role focuses on GxP CSV activities to ensure data integrity and regulatory compliance.

The position suits a professional with strong CSV background in pharma/biotech devices, aiming to impact a high-growth, high-integrity setting. Work Location: Sydney, Australia. Employment Type: Full Time.

Qualifications

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

Responsibilities

• 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.

Skills

CSV experience

GAMP 5

Regulatory knowledge

Data integrity

Collaboration

Tools

ERP systems

LIMS

QMS

Equipment software

Job description

CAI seeks a hands-on CSV Specialist to join a cutting-edge therapeutics facility in Australia’s largest health, education, research and innovation precinct. This full‑time role focuses on GxP CSV activities to ensure data integrity and regulatory compliance.

The position suits a professional with strong CSV background in pharma/biotech devices, aiming to impact a high-growth, high-integrity setting. Work Location: Sydney, Australia. Employment Type: Full Time.