CAI
Computer Systems Validation Engineer
About this role
CAI seeks a Computer Systems Validation Engineer to support FDA-regulated industries with computer validation documentation, system assessments, and compliance activities. You'll work across manufacturing platforms like DeltaV, Rockwell, and Emerson systems, ensuring adherence to 21 CFR Part 11 and GAMP guidelines while collaborating with clients on validation projects.
What you'll do
- Author GxP validation documentation including URS, FRS, RTM, and compliance reports
- Generate and execute test protocols and scripts for system validation
- Support CSV activities across MES, DCS, SCADA, batch systems, and manufacturing execution platforms
- Perform system assessments and data integrity remediation
- Review validation plans, risk assessments, and ensure FDA regulatory adherence
- Collaborate with client teams to deliver validation compliance and technical solutions
What they're looking for
- Computer systems validation (3+ years)
- GAMP guidelines and 21 CFR Part 11 knowledge
- Rockwell PharmaSuite and automation platforms
- DeltaV and batch recipe authoring/development
- S88/S95 batch control standards
- Data integrity assessment and remediation
- Emerson and Siemens system experience
- Written and oral technical communication
Benefits
- Professional services firm with 700+ employees globally
- Work on FDA-regulated, mission-critical projects
- Opportunity to support diverse automation platforms
- Established company (since 1996) with stable growth
- Collaborative team environment with core values emphasis
- Domestic and international project exposure
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CAI
CAI provides commissioning, qualification, and validation services for pharmaceutical and life sciences facilities in regulated environments. The company is hiring Validation Engineers to lead CQV activities, develop technical documentation, execute verification protocols at client sites, and manage teams to ensure regulatory compliance and operational readiness.
View all jobs at CAILikely interview questions
- Can you walk us through your experience authoring GxP validation documentation, such as URS, FRS, or RTM? How do you ensure compliance with 21 CFR Part 11 and data integrity principles?
- Describe your hands-on experience with batch control systems like DeltaV or Rockwell PharmaSuite. Which systems have you worked with, and what was your role in recipe authoring or batch recipe development?