CSV Engineer: Pharma & MES Platform Validation

Cagents; Indianapolis (IN); On-site; USD 90,000 - 130,000; Full time

Job summary

CAI is a professional services company established in 1996 with 700+ professionals worldwide, offering commissioning, qualification, validation, startup, project management, and other services for FDA-regulated industries.

We seek a Computer Systems Validation professional to author GxP documentation, create test scripts, and ensure 21 CFR Part 11 compliance across MES, DCS, SCADA, and batch systems, collaborating with client teams to deliver compliant validation solutions.

Qualifications

• Bachelor’s degree in CS or Engineering; equivalent experience may be accepted.
• Minimum of 3+ years of computer systems validation experience.
• Experience in biotech or pharmaceutical environments preferred.
• Familiarity with GAMP and FDA 21 CFR Parts 11, 210, 211.
• Knowledge of S88/S95 batch control standards.
• Experience with Rockwell DeltaV and related systems.
• Willingness to travel domestically and internationally.
• Authorized to work in the U.S. without current or future sponsorship.

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 MES, DCS, SCADA, and batch systems

Skills

Communication

Documentation

Regulatory Knowledge

Education

Bachelor’s degree in Computer Science or Engineering

Tools

Rockwell DeltaV

DeltaV Batch

Rockwell PharmaSuite

FactoryTalk

Wonderware

iFix

Job description

CAI is a professional services company established in 1996 with 700+ professionals worldwide, offering commissioning, qualification, validation, startup, project management, and other services for FDA-regulated industries.

We seek a Computer Systems Validation professional to author GxP documentation, create test scripts, and ensure 21 CFR Part 11 compliance across MES, DCS, SCADA, and batch systems, collaborating with client teams to deliver compliant validation solutions.