CAI ยท 1 day ago
Computer Systems Validation Engineer
Rockville, MD
Full-time
Onsite
Mid Level
$75K/yr - $106K/yr
3+ years expCAI is a 100% employee-owned professional services company that provides commissioning, qualification, validation, and consulting services to FDA-regulated industries. The Computer Systems Validation Engineer will be responsible for authoring validation documentation, generating test protocols, and ensuring compliance with regulatory standards while supporting client engagements across various platforms.
Asset ManagementConsultingProject Management
No H1B
Responsibilities
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
Qualification
Required
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
In-depth understanding of GAMP guidelines and FDA regulations (21 CFR 11, 210, 211)
Familiarity with S88/S95 batch control standards
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
Preferred
Experience in biotech or pharmaceutical environments preferred over medical device
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
Benefits
Comprehensive Health Insurance coverage
24 days of Paid Time Off
ESOP/401K - 15% Company Contribution (US Only)
Company paid Life Insurance
Company paid Long Term Disability
Company
CAI
CAI is a consulting company that provides technical, operational consulting, and project management services.
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Mike Martin
Chief Executive Officer
Phil Pursifull
Chief Financial Officer
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