CSV Engineer — Computer Systems Validation (Pharma/Biotech)

CAI; Boston (MA); On-site; USD 75,000 - 106,000; Full time

Benefits offered by this job

Health Insurance

Paid Time Off

Life Insurance

Long Term Disability

Job summary

CAI, a professional services firm, is seeking a Computer Systems Validation (CSV) specialist to support validation efforts for biopharma/manufacturing systems in the Boston area. The role involves authoring validation documentation, executing test protocols, and ensuring compliance with 21 CFR Part 11 and data integrity standards.

Ideal candidates have a BS/BA in CS/Engineering with 3+ years in CSV, plus experience with Rockwell, DeltaV, and related platforms.

Qualifications

• Bachelor’s degree 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.

Responsibilities

• 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 and contribute to validation plans and risk assessments.
• Support CSV activities across MES, DCS, SCADA, and batch systems.

Skills

GxP validation

Regulatory compliance

Data integrity

Test protocols

Client support

Education

BS/BA in CS/Engineering

Tools

Rockwell PharmaSuite

DeltaV

FactoryTalk

SIMATIC

Job description

CAI, a professional services firm, is seeking a Computer Systems Validation (CSV) specialist to support validation efforts for biopharma/manufacturing systems in the Boston area. The role involves authoring validation documentation, executing test protocols, and ensuring compliance with 21 CFR Part 11 and data integrity standards.

Ideal candidates have a BS/BA in CS/Engineering with 3+ years in CSV, plus experience with Rockwell, DeltaV, and related platforms.