Pharma CSV Specialist: Validate, Govern & Ensure Compliance

Weil Group, Inc; Puerto Rico; On-site; USD 90,000 - 130,000; Full time

Job summary

Weil Group, Inc. seeks an experienced Computer System Validation Specialist to support validation, implementation, and lifecycle management of computerized systems within a regulated pharmaceutical manufacturing environment.

The role requires hands-on CSV execution, documentation development, risk assessments, and ensuring compliance with FDA 21 CFR Part 11, GMP, and GAMP 5. Collaborate with Automation, IT, Engineering, Manufacturing, and QA teams to validate systems like PLCs/SCADA/HMI/DCS/MES,

Qualifications

• Hands-on CSV in pharma/biotech or FDA-regulated environments.
• Experience developing, reviewing and executing validation protocols and lifecycle docs.
• Knowledge of FDA 21 CFR Part 11, GMP, GAMP 5, and CSV principles.
• Risk assessments, traceability, validation testing, deviations, and change control.

Responsibilities

• Plan, coordinate, and execute CSV activities through system lifecycle.
• Develop and review Validation Plans, URS, FS, IQ/OQ/PQ, VSRs.
• Ensure systems meet acceptance criteria and regulatory expectations.
• Perform risk-based validation to determine testing scope and methods.
• Maintain validated state during lifecycle and support deviations/change controls.

Skills

English communication

Spanish communication

Education

Bachelor's degree in Engineering / CS / Information Systems

Job description

Weil Group, Inc. seeks an experienced Computer System Validation Specialist to support validation, implementation, and lifecycle management of computerized systems within a regulated pharmaceutical manufacturing environment.

The role requires hands-on CSV execution, documentation development, risk assessments, and ensuring compliance with FDA 21 CFR Part 11, GMP, and GAMP 5. Collaborate with Automation, IT, Engineering, Manufacturing, and QA teams to validate systems like PLCs/SCADA/HMI/DCS/MES,