GxP CSV Engineer: Pharma/Biotech Validation Expert

CAI; Princeton (NJ); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Comprehensive Health Insurance

24 days of Paid Time Off

Company paid Life Insurance

Company paid Long Term Disability

Job summary

CAI is seeking a Computer Systems Validation professional to support CSV activities across MES, DCS, SCADA, and batch systems in a pharmaceutical/biotech context. You will author validation documentation, develop and execute test protocols, and ensure data integrity in line with 21 CFR Part 11.

Travel domestically and internationally as required; will collaborate with client teams to ensure validation compliance and successful delivery.

Qualifications

• Bachelor’s degree or higher in a related field; equivalent experience accepted.
• Minimum 3+ years of experience in computer systems validation in biotech/pharma environments preferred.
• Strong knowledge of GAMP guidelines and FDA regulations (21 CFR 11, 210, 211).
• Experience with multiple automation and manufacturing execution systems is highly desirable.
• Excellent English communication, written and spoken.

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.

Skills

GxP validation

Data integrity

Client communication

Project management

Travel flexibility

Education

Bachelor’s degree in Computer Science, Engineering, or related field

Tools

Rockwell PharmaSuite

Rockwell Automation platforms

Emerson DeltaV

DeltaV Batch

Emerson Syncade

PI

GE

ABB

Siemens

Honeywell

PAS-X

FactoryTalk

FactoryLogix

PLM

Simatic

iFix

Wonderware

Job description

CAI is seeking a Computer Systems Validation professional to support CSV activities across MES, DCS, SCADA, and batch systems in a pharmaceutical/biotech context. You will author validation documentation, develop and execute test protocols, and ensure data integrity in line with 21 CFR Part 11.

Travel domestically and internationally as required; will collaborate with client teams to ensure validation compliance and successful delivery.