Description

You will act as the CSV owner for major site and process improvement projects, ensuring regulatory compliance and maximizing efficiency.

Responsibilities

• Assess systems risks and review change requests and test scripts.
• Draft protocols and initiate/review GMP documentation revisions.
• Execute all aspects of the QMS process, including Change Control (DCS/DeltaV and MES/Syncade), Deviations, and CAPAs.
• Identify and implement industry best practices during project scoping.
• Work with CSV team members to identify roadblocks and 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).
• Experience with DeltaV is preferred.
• Prior project leadership experience in the Biotech/Pharma or biologics industry.
• Strong attention to detail and proven ability to work independently.

Key Skills

Education

Any Gradute