GxP CSV Specialist: Validation Lead for Regulated Systems

ECHO Consulting Group Inc; Manatí (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

ECHO Consulting Group, Inc. in Manatí, PR is seeking a CSV Specialist to plan, execute, and document validation of GxP computerized systems in pharma manufacturing, ensuring compliance with FDA 21 CFR Part 11 and global standards.

You will develop validation deliverables (IQ/OQ/PQ, URS, and reports) and collaborate with IT, QA, and manufacturing to support audits and change controls. Required 5+ years in computer system validation, a Bachelor's degree, experience with LIMS/MES/ERP/SAP, and

Qualifications

• Bachelor's degree in a related field.
• 5+ years in computer system validation in pharma/biotech/medical devices.
• Experience validating LIMS, MES, SCADA, ERP (SAP), EDMS, or BMS.
• Familiarity with Agile/DevOps validation and CSA is a plus.
• Experience supporting regulatory inspections (FDA/EMA).

Responsibilities

• Develop, review, and execute validation deliverables (IQ/OQ/PQ, validation plans, URS, and reports).
• Apply GAMP 5 risk-based validation to each system.
• Validate GxP systems (LIMS, MES, ERP, EDMS, BAS, historians) and interfaces.
• Ensure compliance with 21 CFR Part 11, Annex 11, and data integrity.
• Author and execute test scripts, document deviations, and investigate CAPAs.
• Maintain validated state through periodic reviews and change control.
• Collaborate with IT, QA, Engineering, and end users for implementations.
• Support audits/regulatory inspections with validation docs and inspector responses.
• Maintain GDP-compliant audit-ready documentation.
• Contribute to site validation master plans and SOPs.

Skills

GAMP 5

21 CFR Part 11

Annex 11

Data integrity

IQ/OQ/PQ

SDLC

Risk-based validation

Cross-functional communication

eQMS

MS Office

Education

Bachelor's degree

Tools

SAP

eQMS

Job description

ECHO Consulting Group, Inc. in Manatí, PR is seeking a CSV Specialist to plan, execute, and document validation of GxP computerized systems in pharma manufacturing, ensuring compliance with FDA 21 CFR Part 11 and global standards.

You will develop validation deliverables (IQ/OQ/PQ, URS, and reports) and collaborate with IT, QA, and manufacturing to support audits and change controls. Required 5+ years in computer system validation, a Bachelor's degree, experience with LIMS/MES/ERP/SAP, and