Description

You own computerized system validation (CSV) for major site and process improvement projects, ensuring regulatory compliance and operational efficiency.

This role is hybrid.

Responsibilities

• Assess system risks and review change requests and test scripts.
• Draft protocols and initiate or review GMP documentation revisions.
• Execute the full QMS process, including Change Control (DCS/DeltaV and MES/Syncade), Deviations, and CAPAs.
• Identify and implement industry best practices during project scoping.
• Collaborate with the CSV team to identify roadblocks and drive efficiencies in improvement projects.

Required Skills

• 5+ years of experience in equipment and/or computer validations.
• Working experience with Controls Automation and Process Control Systems.
• Experience with Distributed Systems and Manufacturing Execution Systems (MES).
• Prior project leadership experience in the Biotech/Pharma or biologics industry.
• Strong attention to detail and proven ability to work independently.
• Experience with DeltaV is preferred.

Preferred Skills

• Demonstrated leadership in complex validation projects.
• Deep expertise in DeltaV and Syncade environments.

Key Skills

Education

Any Gradute