Senior CSV Engineer: GxP Validation & Data Integrity Leader

Caiready; Sydney; Hybrid; AUD 90,000 - 130,000; Full time

Job summary

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.

Qualifications

• 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

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 validation

GxP

Regulatory knowledge

Data integrity

ERP validation

LIMS validation

Tools

QMS software

ERP systems

LIMS software

Job description

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.