Senior CSV Engineer

About the role

We are looking for a Senior CSV Engineer to join PQE Group’s Melbourne team, supporting computerised systems used in pharmaceutical and medical-device manufacturing. The role involves ensuring that all regulated systems meet GxP, data-integrity and 21 CFR Part 11 requirements.

Key responsibilities

• Lead Computer System Validation (CSV) activities for GxP‑regulated computerized systems.
• Review existing validation documentation, perform GAP assessments and close identified gaps.
• Prepare and maintain validation deliverables such as URS, FS, DS, IQ, OQ, PQ and final validation reports.
• Manage change control, deviation handling and risk assessments related to computerized systems.
• Verify compliance with GAMP5, data‑integrity standards and 21 CFR Part 11.
• Support internal and external audits, inspections and regulatory submissions.
• Collaborate with cross‑functional teams, vendors and quality assurance.

Required profile

• Minimum 5 years of experience in CSV within the pharmaceutical or medical‑device industry.
• Strong knowledge of GxP regulations (GMP, 21 CFR Part 11, EU Annex 11) and GAMP5.
• Ability to work independently in fast‑paced project environments.
• Excellent problem‑solving and communication skills in English.

Required skills

• Computer System Validation (CSV) lifecycle management.
• GAMP5 methodology.
• 21 CFR Part 11 and EU Annex 11 compliance.
• Data‑integrity principles.
• Preparation of URS, FS, DS, IQ, OQ, PQ documentation.

What we offer

• Opportunity to work on international, regulated projects.
• Multicultural environment with collaboration across Europe, Asia and the Americas.
• Professional development in the pharmaceutical and medical‑device sectors.