CQV Engineer - Documentation

Role Overview: We are seeking experienced CQV professionals to support a documentation review mission on site. The successful candidates will play a key role in ensuring that commissioning, qualification, and validation documentation meet regulatory and project standards. Key Responsibilities:

• Perform detailed reviews of CQV documents, including but not limited to protocols, reports, and supporting records.
• Verify documentation compliance with cGMP, GAMP, regulatory guidelines, and the sites internal quality standards.
• Identify gaps, inconsistencies, or non-conformances in existing documentation and recommend corrective actions.
• Collaborate with site CQV, engineering, and quality teams to clarify requirements or resolve discrepancies.
• Track and report progress of documentation reviews and findings.
• Support any remediation or additional documentation as required based on review outcomes. Key Requirements:
• Demonstrable experience within CQV in the pharmaceutical or biotech sector, with particular focus on documentation review.
• Strong understanding of commissioning, qualification, validation procedures, and associated regulatory requirements (e.g., FDA, EMA).
• Excellent attention to detail; able to identify gaps and drive improvements in documentation.
• Familiarity with industry standards and best practices (e.g., cGMP, GAMP, ASTM E2500).
• Effective communication and teamwork skills.
• Track record in successful documentation remediation projects is a desirable.