Computer System Validation Engineer

Pennsylvania, United States

Position Overview

We are looking for an experienced CSV Engineer to support the validation and lifecycle management of computerized systems in GMP-regulated manufacturing environments. The role bridges automation, IT, and quality compliance, ensuring validated systems maintain data integrity, regulatory compliance, and operational excellence.

Key Responsibilities

• Lead and execute Computer System Validation (CSV) activities in line with GxP, FDA, and EU GMP requirements
• Develop, review, and manage validation documentation, including URS, FS, DS, IQ/OQ/PQ protocols, risk assessments, and traceability matrices
• Support commissioning and qualification of Building Management Systems (BMS) and Environmental Management Systems (EMS)
• Validate and maintain DeltaV hardware, applications, and software environments
• Oversee MES validation for Production and Quality modules
• Integrate and validate industrial data platforms such as HighByte and Kepware
• Support automation and scheduling platforms (Dynamic Equipment Scheduler, Green Button Go)
• Ensure validated state compliance for asset management and change control platforms (OctoPlant)
• Contribute to validation for advanced manufacturing systems like Cellular Origins Constellation
• Collaborate cross-functionally with QA, IT, Engineering, and Operations teams

Required Qualifications

• Bachelor s degree in Engineering, Computer Science, or related field
• Proven CSV experience in pharmaceutical, biotech, or advanced manufacturing environments
• Strong knowledge of GMP, GAMP 5, 21 CFR Part 11, and EU Annex 11
• Hands-on experience with DeltaV systems (hardware, application, software)
• Experience validating MES Production and Quality modules
• Familiarity with industrial data integration, OPC connectivity, and automation scheduling tools
• Excellent documentation, risk assessment, and stakeholder communication skills

Preferred Qualifications

• Experience in cell therapy or highly automated manufacturing environments
• Strong understanding of data integrity principles and audit readiness
• Ability to manage multiple validation projects simultaneously