CAI
Computer Systems Validation Engineer
About this role
CAI seeks a Computer Systems Validation Engineer to support FDA-regulated manufacturing clients by authoring GxP validation documentation, executing test protocols, and ensuring 21 CFR Part 11 compliance across multiple automation platforms. You'll work with enterprise systems like Rockwell, DeltaV, and Emerson technologies while collaborating directly with clients on validation strategy and data integrity remediation.
What you'll do
- Author and review GxP validation documentation including URS, FRS, RTM, and compliance reports
- Generate and execute test protocols and scripts for computer systems validation activities
- Support CSV engagements across MES, DCS, SCADA, and batch manufacturing platforms
- Perform system assessments and data integrity remediation for FDA-regulated environments
- Collaborate with client teams to ensure validation compliance and successful delivery
- Apply GAMP guidelines and develop batch recipes using S88/S95 standards and platforms like DeltaV
What they're looking for
- Computer Systems Validation (CSV) and GxP documentation
- 21 CFR Part 11 and FDA compliance (Parts 210, 211)
- Rockwell PharmaSuite and automation platforms
- Emerson DeltaV and DeltaV Batch systems
- S88/S95 batch control standards and recipe authoring
- Test protocol development and execution
- Data integrity assessment and remediation
- GAMP guidelines and risk assessment
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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
- Describe your experience authoring URS and FRS documentation for computer system validations. How did you ensure alignment with client requirements and FDA expectations?
- Walk us through a specific example where you remediated data integrity issues in a regulated manufacturing environment. What was your approach and what was the outcome?