Open to opportunities

Azmat Ullah

@azmatullah

Message

Senior Computer Systems Validation and Business Analyst with 22 years in pharmaceutical informatics.

United States

Message

What I'm looking for

I seek senior validation or informatics roles where I can lead CSV/CSA implementations, improve validation processes, mentor teams, and deliver compliant LIMS/SDMS/CDS solutions.

I am a seasoned Computer Systems Validation (CSV) specialist and Business Analyst with over 22 years in IT, including more than 12 years focused on validation, informatics and business analysis for pharmaceutical and biotech clients. I have led CSV/CSA validation efforts, technical implementations, integrations and user training across LIMS, SDMS, CDS, MES and related systems.

My strengths include planning and executing IQ/OQ/PQ, authoring and reviewing URS/FRS/validation protocols and summary reports, risk analysis, gap assessments and test strategy (functional, regression, integration, UAT). I have deep domain experience with Empower, Chromeleon, LabWare LIMS, STAR LIMS, Sample Manager, MODA-EM, Nugenesis, UNIFI and associated QA/regulatory controls (21 CFR Part 11, cGMP, GAMP5).

I excel at partnering with cross-functional teams, guiding clients through upgrades and global implementations, and improving validation processes. I bring proven leadership in validation projects, strong communication, training and user-support skills, and hands-on experience with AWS/Databricks ETL, SQL, scripting and QA tooling to ensure compliant, fit-for-purpose informatics solutions.

Experience

Work history, roles, and key accomplishments

Current

Sr. Validation Software Specialist

Current

Amgen Pharmaceutical (Milestone Technologies)

Jul 2025 - Present (4 months)

Led ETL validation for Empower and Chromeleon data ingestion into Databricks via AWS, authored and executed validation protocols (IQ/OQ/PQ) and drove data integrity and CSA/CSV deliverables to support regulatory compliance.

CSV Chromeleon Databricks AWS

Sr. Validation Software Specialist

Sterigenics

May 2024 - Jun 2025 (1 year 1 month)

Planned and executed validation activities across multiple sites, managed audit trail and user access reviews, and delivered IQ/OQ/PQ protocols and validation reports ensuring regulatory compliance.

Audit Trail Review GxP Risk Assessment

Computer Systems Validation Specialist

KBI BioPharma

Oct 2021 - Jan 2024 (2 years 3 months)

Supported implementations of ComplianceWire, LIMS, SAP and lab equipment by performing requirements analysis, gap assessment, drafting and executing IOQ/PQ, and creating CSA-based validation deliverables.

LIMS MODA EM CSA Gap Analysis Requirement gathering Data Integrity

Sr. Business Analyst

LabCorp

Apr 2021 - Oct 2021 (6 months)

Supported LabWare LIMS v7 global upgrade by performing requirements analysis, gap identification, test case development and execution (functional, regression, integration) and stakeholder training.

Functional Testing Regression Testing Integration Testing

Sr. Business Analyst

FUJIFILM Diosynth Biotechnologies

Nov 2020 - Oct 2021 (11 months)

Led LabWare LIMS v8 implementation activities across multiple sites, performed requirements and gap analysis, produced validation artifacts (URS, FRS, IQ/OQ/PQ) and authored SOPs and training materials.

URS FRS SOPs Training Gap Analysis

Sr. Lab Validation Analyst

PerkinElmer (via MNA Computers)

Aug 2020 - Nov 2020 (3 months)

Supported NuGenesis SDMS v9 upgrade and data migration, analyzed business requirements, and executed validation deliverables (IQ/OQ/PQ) while coordinating vendor and client activities.

Data Migration Validation Chromeleon

Sr. CSV Consultant

Waters Corporation

Nov 2019 - May 2020 (6 months)

Analyzed global requirements for Empower and NuGenesis implementations, authored validation deliverables (URS, FRS, IQ/OQ/PQ), created test cases and led functional, integration and UAT testing with business users.

URS FRS Test Case Creation UAT

Sr. CSV Analyst

AveXis (Novartis)

Nov 2018 - Oct 2019 (11 months)

Served as CSV lead for STARLIMS v11.1 and Empower implementation, producing validation artifacts, managing risk/issues, and coordinating testing and training to meet cGMP and regulatory requirements.

CSV URS FRS Risk Management Training

Validation Lead / Business Analyst

Biogen

Jun 2018 - Nov 2018 (5 months)

Led validation for LabWare LIMS v7 and Emerson Syncade MES integration and Oracle EBS workstreams, authored validation documentation and managed testing to ensure on-time, compliant releases.

Emerson Syncade EBS Validation Lead Test Management