CSV Engineer

Job Description:
The CSV Engineer will serve as an individual contributor responsible for ensuring compliance with industry regulations and standards while driving efficiency in site and process improvement projects. This role requires expertise in computer system validation, controls automation, and GMP documentation, with a focus on DeltaV and Syncade MES systems. The engineer will collaborate with the CSV team to identify roadblocks, assess risks, and implement best practices across critical systems.
Responsibilities:

• ct as CSV owner for major site and process improvement projects.
• Conduct risk assessments of systems and processes.
• Review change requests, test scripts, and draft validation protocols.
• Initiate and review GMP documentation revisions.
• Execute QMS processes including.
• Change Control (DeltaV, Syncade MES).
• Deviations.
• CAPAs.
• Collaborate with cross-functional teams to ensure compliance with regulatory requirements and industry standards.
• Provide input during project scoping to identify efficiencies and potential roadblocks.

Requirements:

• Bachelor's degree in engineering, Computer Science, Life Sciences, or related field.
• dvanced degree (Master's) preferred but not mandatory.
• dditional certifications in CSV, GMP, or Quality Systems are a plus.
• Substantial hands-on experience in equipment and/or computer system validations.
• Strong working knowledge of Controls Automation, Process Control Systems, Distributed Systems, and MES (DeltaV preferred).
• Prior experience leading projects in Biotech, Pharma, or biologics industries.
• Proven ability to work independently, with strong attention to detail and ability to meet deadlines.