Computer System Validation (CSV) Specialist

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 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.