Computer System Validation (CSV) Specialist

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 is a leader in providing solutions for the pharmaceutical, biotechnology, medical devices, and food industries. ECHO Consulting Group delivers high-quality solutions in CQV, quality management, regulatory compliance, manufacturing support, and project management. We are committed to offering exciting career opportunities in a workplace that values trust, respect, teamwork, creative talent, enthusiasm, and diligence. We are looking for talented professionals who are passionate about quality, collaboration, and delivering results. We believe great talent deserves great rewards. That’s why we offer a competitive compensation package and professional development.

Summary

The CSV Specialist is responsible for planning, executing, and documenting computer system validation activities for GxP-regulated computerized systems within a pharmaceutical manufacturing environment. This role ensures that systems used in manufacturing, laboratory, and quality operations comply with FDA 21 CFR Part 11, GAMP 5, and applicable global regulatory requirements throughout the system lifecycle.

Responsibilities

• Develop, review, and execute validation deliverables including Validation Plans, User Requirements Specifications (URS), Functional/Design Specifications, Risk Assessments, IQ/OQ/PQ protocols, and Validation Summary Reports.
• Apply a risk-based approach (GAMP 5) to determine the appropriate level of validation rigor for each computerized system.
• Validate GxP systems such as LIMS, MES, ERP, EDMS, building automation systems (BAS), historians, and other manufacturing/quality-related software and equipment 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 root cause investigations and CAPAs related to system discrepancies.
• Maintain the validated state of systems through periodic reviews, change control assessments, and revalidation activities.
• Collaborate with IT, Quality, Engineering, and end users to support system implementations, upgrades, migrations, and decommissioning.
• Support internal and external audits/regulatory inspections by providing validation documentation and responding to inspector questions.
• Maintain accurate and audit-ready documentation in accordance with Good Documentation Practices (GDP).
• Contribute to and help maintain site validation master plans (VMP) and SOPs related to computer system validation.

Education

Bachelor's degree in Computer Science, Engineering, Life Sciences, Information Technology, or a related field required.

Location

Manatí, PR

Preferred Qualifications

• 5+ years of experience in Computer System Validation within a pharmaceutical, biotech, or medical device environment.
• Experience validating systems such as LIMS, MES, SCADA, ERP (e.g., SAP), EDMS, or Building Management Systems (BMS).
• Familiarity with Agile/DevOps validation approaches and Computer Software Assurance (CSA) is a plus.
• Experience supporting FDA, EMA, or other regulatory agency inspections.
• ASQ CQE/CSSBB or similar quality certification is a plus.

Skills

• Strong working knowledge of GAMP 5, 21 CFR Part 11, Annex 11, and data integrity requirements.
• Proficiency in authoring and executing validation protocols (IQ/OQ/PQ) and technical documentation.
• Solid understanding of SDLC (Software Development Life Cycle) and risk-based validation methodologies.
• Strong analytical and problem-solving skills for troubleshooting and deviation investigations.
• Excellent written and verbal communication skills, with the ability to interface with cross-functional teams (IT, QA, Engineering, Manufacturing).
• Detail-oriented with strong organizational and time-management skills.
• Proficiency with Microsoft Office and electronic quality management systems (eQMS).

Equal Employment Opportunity

ECHO Consulting Group, Inc. is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or membership in any other class protected by federal, state, or local law.

We assure you that your opportunity for employment with ECHO Consulting Group, Inc. depends solely on your qualifications.