GxP CSV Specialist: Validation Lead for Regulated Systems

Echo-Consulting-Group; Manatí (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

ECHO Consulting Group, Inc. is seeking a CSV Specialist to plan, execute, and document computer system validation activities in a pharma manufacturing environment.

You will ensure that systems used in manufacturing, labs, and quality operations comply with FDA 21 CFR Part 11, GAMP 5, and global requirements across the lifecycle. The ideal candidate has 5+ years in CS validation, experience with LIMS/MES/ERP/EDMS, and familiarity with audits.

Qualifications

• The candidate must have 5+ years in computer system validation in pharma/biotech/medical devices.
• Familiarity with GxP regulatory requirements and risk-based validation approaches.
• Experience supporting FDA/EMA inspections is a plus.

Responsibilities

• Develop, review, and execute validation deliverables (IQ/OQ/PQ protocols, VMPs, reports).
• Apply GAMP 5 risk-based validation to determine appropriate rigor.
• Validate systems like LIMS, MES, ERP, EDMS, BAS, historians and interfaces.
• Ensure 21 CFR Part 11, Annex 11, and data integrity compliance (ALCOA+).
• Author/test scripts, document deviations, support CAPAs and investigations.
• Maintain validated state via periodic reviews and change control.
• Support audits/regulatory inspections with documentation and responses.
• Contribute to site validation master plans and SOPs.

Skills

GAMP 5

21 CFR Part 11

ALCOA+

IQ/OQ/PQ

GDP

eQMS

SDLC

Education

Bachelor's degree in Computer Science, Engineering, Life Sciences, IT, or related field

Tools

LIMS

MES

SCADA

ERP (SAP)

EDMS

BMS

Job description

ECHO Consulting Group, Inc. is seeking a CSV Specialist to plan, execute, and document computer system validation activities in a pharma manufacturing environment.

You will ensure that systems used in manufacturing, labs, and quality operations comply with FDA 21 CFR Part 11, GAMP 5, and global requirements across the lifecycle. The ideal candidate has 5+ years in CS validation, experience with LIMS/MES/ERP/EDMS, and familiarity with audits.