CSV Engineer - Katalyst CRO : Job Details

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• Develop and execute CSV protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for manufacturing equipment.
• Collaborate closely with automation and validation teams to ensure systems meet project and regulatory compliance standards.
• Manage the document lifecycle, including creation, revision, and storage, in compliance with project documentation systems.
• Participate in weekly project meetings to coordinate with system owners and management for alignment on project needs and issue resolution.
• Conduct risk assessments and generate compliance reports, managing deviations and ensuring all required documentation meets quality and regulatory standards.
• Oversee vendor interactions, including reviewing and tracking vendor deliverables and system qualifications.

• Bachelor's degree in a relevant field (e.g., Engineering, Computer Science, Life Sciences).
• Minimum of 5 years of experience in Computer System Validation in a GMP-regulated environment, ideally within pharmaceuticals or biotechnology.
• Strong knowledge of regulatory compliance requirements (e.g., FDA regulations, cGMP standards) and quality systems.
• Experience with DeltaV control systems and document management systems.
• Excellent organizational, communication, and documentation skills.
• Ability to work effectively both independently and as part of an integrated project team.

• Associate

• Contract

• Pharmaceutical Manufacturing

This job is active and accepting applications.