Senior CSV Validation Engineer (GxP)

PROFESSIONAL SUMMARY

Senior Computer System Validation (CSV) and Validation Engineer with 5+ years of experience in pharmaceutical, biotechnology, and life sciences environments. Experienced in validating GxP computerized systems including LIMS, MES, CDS, ERP, and quality systems in compliance with FDA 21 CFR Part 11, GAMP 5, and EU Annex 11. Skilled in authoring and executing URS, FS, DS, IQ, OQ, PQ, RTM, UAT, and Validation Summary Reports. Proven experience supporting FDA and internal audits, managing deviations, CAPAs, change controls, and maintaining inspection-ready validation documentation.

TOOLS & APPLICATIONS

LabVantage

LABWORKS

Empower

Chromeleon

PharmaSuite (MES)

SAP (ERP)

TrackWise

Veeva Vault

HP ALM / Quality Center

JIRA

SharePoint

Microsoft Visio

CORE COMPETENCIES & EDUCATION

CORE COMPETENCIES

Computer System Validation (CSV)

GAMP 5 & 21 CFR Part 11 / 210 / 211

IQ / OQ / PQ Protocol Authoring & Execution

Risk-Based Validation

URS / FS / DS / RTM / VSR Authoring

UAT Facilitation & Test Script Development

FDA Audit Readiness

CAPA & Deviation Management

Change Control Management

SOP Authoring & Review

Data Integrity & ALCOA+

Audit Trail Review

Periodic Review & Revalidation

Disaster Recovery & Backup/Restore Testing

Infrastructure Qualification

SDLC & V-Model

REGULATORY FRAMEWORKS

GAMP 5

21 CFR Part 11 / 210 / 211

EU Annex 11

FDA PV Guidance 2011

ICH Q2(R1)

ISO 9001 / cGMP / GxP

EDUCATION

M.S. – Information Technology Management

Concordia University 2023

PROFESSIONAL EXPERIENCE

Senior CSV & Validation Engineer • Biogen Cambridge, MA June 2025 – Present

Developed and executed IQ/OQ/PQ protocols for LIMS upgrades and MES enhancements in a biologics manufacturing environment, aligned to GAMP 5 categorization and the site's validation master plan.

Prepared URS, FS, DS, RTM, and Validation Summary Reports for newly integrated GxP systems, tracking requirements from initial intake through test execution and formal closure.

Conducted system-level risk assessments with IT, QA, and manufacturing operations; translated business requirements into validation strategies compliant with 21 CFR Part 11 and EU Annex 11.

Managed 20+ change control records and deviation reports in TrackWise and Veeva Vault, assessing impact and closing out CAPAs across several concurrent projects.

Worked through protocol deviations and test discrepancies with QA and manufacturing stakeholders to get root cause identified and resolved before batch disposition.

Kept the validation documentation repository in SharePoint organized, so approval records were easy to pull whenever QA or a regulatory inspection came up.

Senior CSV Engineer • PerkinElmer Shelton, CT September 2024 – May 2025

Delivered full-lifecycle CSV support for Chromeleon and Empower CDS platforms, authoring and executing IQ/OQ/PQ protocols from installation qualification through performance verification.

Performed GAMP 5 category classification exercises for validated systems; produced category justification documentation based on business criticality and patient risk.

Developed site-specific validation master plans in collaboration with client QA teams, harmonizing validation approaches across multiple product lines and instrument families.

Executed functional, integration, and regression testing for software version upgrades, working issues against pre-approved acceptance criteria until each project closed out.

Compiled complete validation packages including RTMs, IQ/OQ/PQ protocols, and VSRs to support 3 QA audits and 2 inspector reviews.

Conducted periodic reviews for legacy validated systems; identified revalidation triggers and coordinated corrective actions with system owners and IT administrators.

Ran disaster recovery and backup/restore test cycles for validated CDS platforms, documenting test evidence and audit trails per ALCOA+ principles.

CSV Engineer • Genentech South San Francisco, CA January 2023 – August 2024

Wrote and executed OQ/PQ protocols for LabVantage LIMS configuration validation and MES qualification under cGMP, coordinating scheduling with QA, validation, and operations teams.

Developed OQ/PQ protocols for SCADA, building automation systems, and process control applications, documenting all test evidence for regulatory submissions.

Performed UAT for GxP systems by facilitating sessions with cross-functional SMEs; converted business workflows into formal test scripts with complete execution evidence documented in HP ALM.

Reviewed completed test execution packages for gaps before handing them off to QA for VSR sign-off, flagging missing evidence back to the test team when needed.

Managed 25+ deviation records during protocol execution, working through impact analysis with QA and helping close out CAPAs before the validation summary report went up for approval.

Contributed to a site-wide CSV SOP refresh, drafting updated procedures for system lifecycle management, access control validation, audit trail review, and backup/recovery testing.

Supported an FDA PAI inspection; all three critical system validation packages cleared without any validation-related observations.

Validation Engineer • Mankind Pharma India June 2020 – December 2021

Performed IQ/OQ for autoclave systems, HVAC, purified water systems, and analytical balances across solid dosage and sterile formulation areas; compiled qualification packages for QA review.

Supported process validation for tablet compression and coating operations; contributed to process capability studies per FDA 2011 Process Validation Guidance.

Authored and reviewed SOPs for qualification activities, instrument calibration, and validation change control; applied during internal quality audits.

Participated in CAPA investigations for out-of-tolerance calibration and equipment deviations; documented root cause analyses and preventive actions in the site tracking system.

Compiled validation documentation packages including raw data, protocol summary reports, and RTMs for QA review and regulatory submission readiness.

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