CSV / CQV Engineer

About the role

We are seeking a CSV / CQV Engineer to support validation activities in a regulated biopharmaceutical manufacturing environment. The role will focus on Computer System Validation (CSV) while also supporting equipment qualification and CQV activities.

Responsibilities

• Support Computer System Validation activities.
• Validate GMP computerized systems.
• Prepare and execute validation protocols.
• Support validation planning and risk assessments.
• Maintain validation documentation and traceability.
• Document testing activities and results.
• Investigate and document validation discrepancies.
• Support equipment qualification and CQV activities.
• Work with Quality, Engineering, Automation, Manufacturing, and IT teams.
• Support multiple validation projects and workstreams.

Requirements

• 5–10 years of validation experience in a GMP-regulated environment.
• Strong experience in Computer System Validation (CSV).
• Experience with GMP computerized systems.
• Knowledge of the CSV lifecycle.
• Understanding of GMP and data integrity requirements.
• Experience with equipment validation or CQV.
• Experience executing validation protocols.
• Experience documenting and resolving validation discrepancies.
• Strong cross-functional communication skills.

Qualifications

ValGenesis experience is a plus.