Computer Systems Validation Engineer

About the role

Are You Ready? CAI is a professional services company established in 1996 that has grown to more than 700 people worldwide. We provide commissioning, qualification, validation, startup, project management, and other consulting services associated with operational readiness to FDA-regulated and other mission-critical industries. Our approach is simple—we put the client’s interests first, we don’t stop until it’s right, and we do whatever it takes to get there. Our Foundational Principles: We act with integrity We serve each other We serve society We work for our future We work diligently to accomplish team goals and live our core values: Team Before Self Respect for Others Can-Do Attitude This position could report to Rockville, MD or Frederick, MD.

Responsibilities

• Documentation & Compliance
  • Author GxP computer validation documentation (e.g., URS, FRS, RTM, summary reports)
  • Generate and execute test protocols and scripts
  • Ensure adherence to 21 CFR Part 11 and data integrity principles
  • Review and contribute to validation plans and risk assessments
• System & Industry Expertise
  • Support CSV activities across various platforms including MES, DCS, SCADA, and batch systems
  • Engage with major systems and platforms such as Rockwell PharmaSuite, Rockwell Automation platforms, Emerson DeltaV, DeltaV Batch, Emerson Syncade, PI, GE, ABB, Siemens, Honeywell, PAS-X, FactoryTalk, FactoryLogix, PLM, Simatic, iFix, Wonderware
  • Apply knowledge of GAMP and compliance expectations (21 CFR Parts 210, 211, 11)
  • Utilize familiarity with S88/S95 batch control standards
  • Apply working knowledge of recipe authoring, batch recipe development, and S88-based recipe structures across systems such as DeltaV and Rockwell
• Client Support & Technical Execution
  • Support client engagements with strong customer-service orientation
  • Perform system assessments and remediation related to data integrity
  • Collaborate with client teams to ensure validation compliance and delivery

Requirements

• Bachelor’s degree (BS/BA) in Computer Science, Engineering, or related field; equivalent experience may be accepted