FDA-Regulated CSV Engineer – Automation & Validation

Cagents; Boston (MA); Hybrid; USD 110,000 - 150,000; Full time

Job summary

CAI, a professional services company, is seeking a System Validation Lead in Boston, MA. The role focuses on GxP computer validation across MES, DCS, SCADA, and batch systems, ensuring 21 CFR Part 11 compliance and data integrity.

Ideal candidates have a BS in CS/Engineering and 3+ years of validation experience in biotech or pharma environments. You will author validation documentation, develop test scripts, and collaborate with client teams to deliver compliant solutions.

Qualifications

• Bachelor’s degree in CS/Engineering or related field.
• Minimum 3+ years in computer systems validation.
• Experience in biotech or pharmaceutical environments preferred.
• Knowledge of GAMP and FDA regulations (21 CFR 11, 210, 211).
• Familiarity with S88/S95 batch control standards.

Responsibilities

• Author GxP 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 and contribute to validation plans and risk assessments.
• Support CSV activities across MES, DCS, SCADA, and batch systems.
• Collaborate with client teams to ensure validation compliance and delivery.

Skills

GxP knowledge

Documentation

Data integrity

FDA regulations

S88/S95 batch control

Education

Bachelor's degree in CS/Engineering

Tools

Rockwell DeltaV

Rockwell PharmaSuite

PI

FactoryTalk

DeltaV

Job description

CAI, a professional services company, is seeking a System Validation Lead in Boston, MA. The role focuses on GxP computer validation across MES, DCS, SCADA, and batch systems, ensuring 21 CFR Part 11 compliance and data integrity.

Ideal candidates have a BS in CS/Engineering and 3+ years of validation experience in biotech or pharma environments. You will author validation documentation, develop test scripts, and collaborate with client teams to deliver compliant solutions.