GxP CSV & Data Integrity Validation Specialist

HUMPHREY N. AWINYO, MBA

Computer System Validation (CSV) Specialist — GxP Computerized Systems, 21 CFR Part 11, GAMP 5, Data Integrity

North Plainfield, NJ 732-***-**** ********.******@*******.*** linkedin.com/in/hnawinyo

PROFESSIONAL SUMMARY

Computer System Validation professional with 12+ years of hands-on experience authoring and executing validation documentation for GxP computerized systems in regulated pharmaceutical, biopharmaceutical, and personal care manufacturing environments. Direct, hands-on experience across the full validation lifecycle — Validation Master Plans, Validation Plans, risk assessments, IQ/OQ/PQ protocols, test scripts, traceability matrices, and Validation Summary Reports — including authoring the Validation Master Plan and leading a global CDS deployment at Janssen Pharmaceuticals, and cleaning validation/CIP qualification at Merck. Deep working knowledge of GAMP 5, 21 CFR Part 11, GxP, and data integrity principles, reinforced by building a Data Integrity and Data Governance framework from the ground up at Takeda Pharmaceuticals that reduced DI violations 75%. Comfortable working cross-functionally with IT, Engineering, Quality, Manufacturing, and system owners throughout the system lifecycle, and supporting change controls, deviations, CAPAs, and audit/inspection readiness. Brings additional program- and team-leadership experience (Bristol Myers Squibb, Takeda) beyond the scope of this role, offering room to grow with an organization's validation practice.

CORE COMPETENCIES

Computer System Validation (CSV) Lifecycle Documentation User Requirements Specifications (URS) Functional/Design Specifications Risk Assessments Validation Plans & Validation Master Plans IQ/OQ/PQ Protocol Authoring & Execution Test Scripts & Traceability Matrices Validation Summary Reports 21 CFR Part 11 / GxP / Data Integrity & Electronic Records-Signatures GAMP 5 Risk-Based Methodology Change Control, Deviations & CAPA Audit & Inspection Readiness Cross-Functional Collaboration (IT, Engineering, Quality, Manufacturing) System Implementation, Upgrades & Periodic Review Support Analytical/QC Testing (HPLC)

PROFESSIONAL EXPERIENCE

Founder Hekima Solutions

Nov 2025 – Present

● Applying a hands-on, builder's approach to advise on and build NEXARIS, an AI-powered CSA lifecycle management platform (in development/testing, not yet commercially released), with modules covering document control, execution logging, and e-signature sign-off.

Senior QA Consultant The Estée Lauder Companies (via TechTriad)

Apr 2024 – Oct 2025 Remote

● Redesigned the CAPA and deviation management process as part of a broader QMS overhaul — restructured how deviations are captured, how CAPA effectiveness is verified, and how closure connects to complaint management and supplier quality documentation.

● Built the client's Computer Software Assurance program from the ground up ahead of final FDA guidance; developed CSA procedures and delivered training to client teams on the new approach.

IT GxP Compliance Manager Bristol Myers Squibb

Oct 2020 – Oct 2023 New Brunswick, NJ (Hybrid)

● Served as system/process owner for Veeva Vault, managing documentation, deviations, and training records supporting qualification of laboratory instrumentation (flow cytometers, PCR/qPCR systems, bioanalytical instrumentation, ELN) for cell and gene therapy operations; reviewed and approved validation protocols.

● Built the business case for and led implementation of ValGenesis, managing the paper-to-electronic validation testing transition and cutting validation cycle time ~60%.

● Served as SME in regulatory and self-inspection audits with zero critical/major findings across FDA/EMA/MHRA/PMDA.

Senior Manager (Consultant, via Wipro) Takeda Pharmaceuticals

2014 – 2019 Multi-site: Deerfield, IL; Brooklyn Park, MN; Konstanz & Düsseldorf, Germany; Osaka & Tokyo, Japan

● Built a Data Integrity and Data Governance framework from the ground up (SOPs, risk-based controls, governance structure, training) across a multi-site, multi-country biopharmaceutical operations program — reduced data integrity violations 75%.

● Led self-inspection audit initiatives across the program and adoption of Documentum for electronic document control, cutting approval cycle time 70%; provided J-SOX audit support for the Japan sites.

Senior Validation Lead (Consultant, via Rose International) Janssen Pharmaceuticals

2011 – 2013 Raritan, NJ

● Authored the Validation Master Plan and led the global Waters Empower 3 CDS deployment, piloting at the Raritan site.

● Identified a gap in the risk assessment during document development and halted the deployment until it was authored and addressed — ensuring the program reached a defensible, audit-ready footing before go-live.

QA Validation Consultant Merck

2010 – 2011

● Gown certified for aseptic areas; performed cleaning validation on CIP (Clean-in-Place) tanks within controlled, classified manufacturing spaces.

Validation Consultant GSK

2009 – 2010

● Supported OT/MES/PLC/SCADA integration qualification.

Analytical Scientist Warner Lambert (Pfizer)

circa 2000

● Tested tablets, liquids, and capsules using HPLC analytical methods in a pharmaceutical manufacturing environment.

QC Chemist Colgate-Palmolive

Late 1990s – Early 2000s

● Performed analytical method transfer to GC and HPLC instrumentation; tested in-process manufacturing samples under ISO 9001 quality systems with authority to request resampling and halt manufacturing until failures were resolved.

EDUCATION

MBA, Management Information Systems — New Jersey Institute of Technology (NJIT)

B.S., Biology — New Jersey City University

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