Computer Systems Validation Engineer

About the role

CAI is a professional services company established in 1996 with over 700 professionals worldwide. We specialize in commissioning, qualification, validation, startup, project management, and consulting services for FDA-regulated and mission-critical industries. Our foundational principles include acting with integrity, serving each other, serving society, working for our future, and diligently achieving team goals while adhering to our core values.

Key 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.

Qualifications and Experience

• Bachelor’s degree (BS/BA) in Computer Science, Engineering, or related field; equivalent experience may be accepted.
• Minimum of 3+ years of experience in computer systems validation.
• Experience in biotech or pharmaceutical environments preferred over medical device.
• In-depth understanding of GAMP guidelines and FDA regulations (21 CFR 11, 210, 211).
• Familiarity with S88/S95 batch control standards.
• Experience with Rockwell platforms, DeltaV systems, and recipe authoring in batch environments strongly preferred.
• Experience with multiple automation and manufacturing execution systems is highly desirable.
• Data integrity assessment/remediation experience is a plus.

Other Requirements

• Excellent oral and written communication skills in English.
• Ability to travel domestically and internationally as required.
• Willingness to work paid overtime when needed.
• Must be authorized to work in the U.S. without current or future sponsorship.