CSV Engineer - FDA/GxP Systems Validation

CAI

Boston (MA)

On-site

USD 90,000 - 130,000

Full time

2 days ago

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Job summary

CAI is a professional services company specializing in commissioning, qualification, validation, startup, and project management for FDA-regulated industries. We seek a validated CSV professional to author documentation, generate test protocols, and ensure 21 CFR 11/data integrity across MES, DCS, SCADA, and batch systems.

The role involves working with Rockwell, DeltaV, PI, and related platforms, with travel as needed to client sites.

Qualifications

Bachelor’s degree in Computer Science, Engineering, or related field; equivalent experience may be accepted.
3+ years of experience in computer systems validation.
Experience in biotech or pharmaceutical environments preferred.
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 preferred.

Responsibilities

Documentation & Compliance: Author GxP computer validation documentation (URS, FRS, RTM, summary reports).
Generate and execute test protocols and scripts.
Ensure adherence to 21 CFR Part 11 and data integrity principles.
Review validation plans and risk assessments.
System & Industry Expertise: Support CSV activities across MES, DCS, SCADA, and batch systems.
Client Support & Technical Execution: Collaborate with client teams to ensure validation compliance and delivery.