CSV Specialist: GxP System Validation for Pharma

ECHO Consulting Group; Manatí (PR); On-site; USD 70,000 - 110,000; Full time

Job summary

ECHO Consulting Group is seeking a CSV Specialist to plan, execute, and document computer system validation activities for GxP-regulated systems in a pharmaceutical manufacturing environment. You will ensure systems comply with FDA 21 CFR Part 11, GAMP 5, and data integrity throughout the lifecycle.

Responsibilities include developing validation deliverables, applying risk-based validation, and collaborating with IT, QA, Engineering, and end users to support audits and system improvements.

Qualifications

• Bachelor's degree in Computer Science, Engineering, Life Sciences, IT, or a related field.
• 5+ years of experience in Computer System Validation within pharmaceutical, biotech, or medical device environments.
• Experience validating LIMS, MES, SCADA, ERP (SAP), EDMS, or Building Management Systems (BMS).
• Familiarity with Agile/DevOps validation approaches and Computer Software Assurance (CSA) is a plus.

Responsibilities

• Develop, review, and execute validation deliverables including Validation Plans, URS, Design Specifications, IP/OQ/PQ protocols, and Validation Summary Reports.
• Apply a risk-based approach (GAMP 5) to determine the appropriate level of validation rigor for each system.
• Validate GxP systems such as LIMS, MES, SCADA, ERP (SAP), EDMS, and BMS interfaces.
• Ensure compliance with 21 CFR Part 11, Annex 11, and data integrity principles (ALCOA+) across validated systems.
• Author and execute test scripts, document deviations, and support investigations and CAPAs.
• Maintain validated state through periodic reviews, change control, and revalidation.
• Collaborate with IT, Quality, Engineering, and end users to support implementations, upgrades, migrations, and decommissioning.
• Support audits/regulatory inspections with validation documentation and inspector responses.
• Maintain GDP-compliant documentation and contribute to validation master plans.

Skills

GAMP 5 knowledge

21 CFR Part 11

Data integrity

IQ/OQ/PQ protocols

Validation documentation

Cross-functional collaboration

SDLC & risk-based validation

Education

Bachelor's degree in Computer Science / Engineering / Life Sciences / IT

Tools

LIMS

MES

SCADA

ERP (SAP)

EDMS

BMS

Job description

ECHO Consulting Group is seeking a CSV Specialist to plan, execute, and document computer system validation activities for GxP-regulated systems in a pharmaceutical manufacturing environment. You will ensure systems comply with FDA 21 CFR Part 11, GAMP 5, and data integrity throughout the lifecycle.

Responsibilities include developing validation deliverables, applying risk-based validation, and collaborating with IT, QA, Engineering, and end users to support audits and system improvements.