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 guide our actions: integrity, serving each other, serving society, working for our future, and diligently achieving team goals.

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
• 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
• 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
• Able 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

Critical Competencies

• Pursues opportunities based on organizational fit and strategy
• Identifies high-impact, innovative solutions
• Satisfies the Customer
• Anticipates and meets client needs
• Delivers high-quality solutions and maintains satisfaction
• Aligns business goals with execution plans
• Allocates resources and builds risk mitigation strategies
• Prioritizes effectively and ensures accountability
• Proactively addresses challenges
• Tailors Communication
• Communicates clearly and professionally
• Adapts style for technical and non-technical audiences
• Builds cross-functional networks
• Promotes collaboration and stakeholder engagement
• Influence Others
• Gains support through sound reasoning
• Promotes innovation and value
• Develops Self and Others
• Demonstrates integrity and commitment to growth
• Builds effective relationships internally and externally

Benefits

• Comprehensive Health Insurance coverage
• 24 days of Paid Time Off
• Company paid Life Insurance
• Company paid Long Term Disability