CQV Engineer

We are working with a leading pharmaceutical manufacturer in Austria who are seeking an experienced Commissioning, Qualification & Validation (CQV) Contractor to support ongoing laboratory and utilities qualification activities. This is a full-time, on-site, 12-month contract requiring strong German language skills.

Role Overview

The CQV Contractor will execute and document qualification and validation activities across QC laboratory equipment and associated utilities, ensuring compliance with GMP and global regulatory standards. The position is suited to a hands-on validation professional with strong technical documentation capabilities and a solid understanding of GAMP 5 and Annex 15.

Key Responsibilities

• Perform qualification activities for QC laboratory instruments and utilities, including balances, HPLC/UPLC, incubators, freezers, pH meters, and stability chambers.
• Prepare and execute:
• IQ/OQ/PQ protocols
• Validation Summary Reports
• Risk Assessments and Traceability Matrices
• Ensure alignment with GAMP 5, Annex 15, ICH Q9, and Data Integrity guidelines.
• Provide support during internal and external audits (FDA, EMA, MHRA, WHO).
• Contribute to development and improvement of CSV/CQV SOPs, templates, and standards.
• Deliver training and guidance to QC and QA teams on validation and data integrity.
• Identify opportunities for process optimisation and digital improvements within QC operations.

Requirements

• Strong experience in CQV within a GMP-regulated pharmaceutical environment.
• Demonstrated expertise in laboratory equipment qualification.
• Fluent German (mandatory).
• Availability for an on-site, full-time 12-month contract in Austria.

What's in it for you

• 12-month full-time contract.
• Exposure to high-profile pharma projects.
• Professional development.
• Cross-functional collaboration.
• Career growth potential.

Contract Details

• Location: Austria
• Duration: 12 months