CSV Specialist: GxP Compliance for Biologics

ProClinical; Sydney; On-site; AUD 120,000 - 170,000; Full time

Job summary

Proclinical is seeking a Computer System Validation (CSV) Specialist to join a pioneering biologics manufacturer in Australia, focusing on validation of regulated computerised systems for GMP operations.

Reporting to the Validation Manager, you will plan, execute, and document CSV activities (IQ, OQ, PQ) and ensure data integrity, audit readiness, and change control across ERP, LIMS, QMS, and other GxP systems.

Qualifications

• Bachelor’s degree in a relevant field and experience in CSV within regulated environments.
• Experience validating software and systems used in GxP operations.
• Strong knowledge of GAMP 5, FDA 21 CFR Part 11, EU Annex 11 and data integrity.

Responsibilities

• Develop and execute CSV protocols (IQ, OQ, PQ) for regulated systems.
• Create and review Validation Plans, Risk Assessments, and Traceability Matrices.
• Ensure compliance with GxP, FDA Part 11, and EU Annex 11 across systems.
• Provide CSV documentation guidance and support audit readiness.
• Collaborate with IT, QC, QA, and Engineering to align validation with requirements.
• Train staff on CSV procedures and drive continuous improvement.

Skills

CSV validation

GxP knowledge

Regulatory compliance

Dokument writing

Cross-functional collaboration

IQ/OQ/PQ

Data integrity

Audit readiness

Change control

SOP development

Education

Bachelor’s degree in computer science, life sciences, engineering, QA

Tools

ERP

LIMS

QMS

GxP systems

Job description

Proclinical is seeking a Computer System Validation (CSV) Specialist to join a pioneering biologics manufacturer in Australia, focusing on validation of regulated computerised systems for GMP operations.

Reporting to the Validation Manager, you will plan, execute, and document CSV activities (IQ, OQ, PQ) and ensure data integrity, audit readiness, and change control across ERP, LIMS, QMS, and other GxP systems.