Senior CSV Engineer — GxP Systems & Data Integrity

Caiready; Sydney; Hybrid; AUD 110,000 - 160,000; Full time

Job summary

CAI seeks a hands-on Computer System Validation (CSV) Specialist for a cutting-edge advanced therapeutics facility in Sydney, Australia. This full-time role focuses on software/system validation in a GxP setting and requires a strong CSV background.

You will lead IQ/OQ/PQ activities across regulated systems, ensure compliance with major regulatory guidelines, and collaborate with IT, QC and business teams. A pathway to influence data integrity programs is available.

Qualifications

• 3+ years’ experience in CSV in pharma, biotech, or medical devices (GxP).
• 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

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

GxP validation

Data integrity

Regulatory knowledge

Detail-oriented

Team player

Adaptability

Tools

ERP

LIMS

QMS

Job description

CAI seeks a hands-on Computer System Validation (CSV) Specialist for a cutting-edge advanced therapeutics facility in Sydney, Australia. This full-time role focuses on software/system validation in a GxP setting and requires a strong CSV background.

You will lead IQ/OQ/PQ activities across regulated systems, ensure compliance with major regulatory guidelines, and collaborate with IT, QC and business teams. A pathway to influence data integrity programs is available.