Hazari S

Senior Computer System Validation (CSV) / Validation Engineer with 8 years of experience in FDA regulated Pharmaceutical, Biotech and Medical Device environments supporting GxP computerized systems. Extensive experience validating Laboratory, Quality, Manufacturing and Labeling systems following GAMP 5 risk based validation methodology. Experienced in Cleaning Validation including MACO calculations, worst-case determination, and PQ strategy development in GMP environments.

Strong expertise in System Development Life Cycle (SDLC) and Software Development Life Cycle validation across implementation, upgrades and migration projects. Proven experience ensuring compliance with 21 CFR Part 11, EU Annex 11, ALCOA+ data integrity principles and global GxP standards. Strong knowledge of contamination control, residue acceptance limits, and risk-based validation approaches.

Skilled in authoring and executing Validation Plans (VP), URS, FS, DS, IQ, OQ, PQ, RTM, Validation Summary Reports (VSR) and Compliance Reports. Hands on experience performing risk assessments (FMEA), impact assessments and change control validation for regulated systems. Expertise in reviewing System Test Scripts, UAT scripts, design specifications, defect management and traceability matrix to ensure regulatory compliance.

Strong experience working with test management and ALM tools such as JIRA, qTest, XRAY for JIRA and ServiceNow ITSM (Vancouver Release). Experienced in validation of enterprise systems such as LIMS, TrackWise, SAP S/4HANA, Veeva Vault, Lab Ware LIMS, Master Control and Labeling systems. Served as Technology Quality representative providing validation guidance aligned with Johnson & Johnson CSV Framework and enterprise SDLC processes.

Collaborated with QA, IT, business stakeholders, validation teams and offshore teams to support multiple validation projects simultaneously. Strong communication, documentation and leadership skills with experience leading validation efforts, mentoring teams and ensuring inspection readiness for FDA and global regulatory audits.

Senior Validation Engineer - Cardinal Health - Dayton, OH

(2024-07)

Responsible for validating enterprise laboratory and labeling platforms supporting pharmaceutical distribution operations to ensure compliance with FDA 21 CFR Part 11 and global GxP standards.

• Led risk based validation activities following GAMP 5 and CSA approach for enterprise laboratory systems and labeling platforms.
• Led Cleaning Validation activities ensuring compliance with GMP and FDA regulatory requirements
• Performed MACO calculations and defined residue acceptance limits for multi-product equipment
• Authored and executed Validation Plans, URS, Functional Specifications, IQ/OQ/PQ protocols and Validation Summary Reports.
• Validated Lab Ware LIMS and Loft ware Nice Label Cloud supporting regulated pharmaceutical operations.
• Conducted risk assessments and impact assessments for system upgrades and infrastructure changes.
• Created and maintained Traceability Matrix linking requirements to test cases and validation evidence.
• Conducted worst-case product selection and soil evaluation based on toxicity and cleanability
• Developed and executed Cleaning Validation PQ protocols, including swab and rinse sampling
• Executed test protocols and coordinated UAT testing with business stakeholders.
• Managed defect lifecycle using JIRA and XRAY test management plugin.
• Coordinated change control and validation activities through ServiceNow ITSM (Vancouver).
• Reviewed system integration documentation, design specifications and data integrity controls.
• Provided Technology Quality oversight and validation guidance aligned with enterprise CSV frameworks.
• Implemented risk-based validation strategies leveraging existing process and historical data
• Ensured compliance with ALCOA+ data integrity principles during system validation activities.
• Supported internal audits and regulatory inspections by maintaining validation documentation and audit readiness.
• Mentored junior validation engineers and collaborated with remote global validation teams.

Sr QA / CSV Engineer - MP Materials - Dallas, TX

(2023-09 - 2024-06)

Validated manufacturing and quality management systems used in rare earth materials processing to ensure regulatory compliance and data integrity.

• Led validation of Manufacturing Execution Systems (MES) and Quality Management Systems following GAMP 5.
• Developed validation documentation including URS, FS, IQ/OQ/PQ and Validation Reports.
• Performed risk assessments and validation impact assessments for system updates and enhancements.
• Supported cleaning validation assessments as part of system and process validation activities
• Collaborated with QA/Manufacturing teams to ensure equipment cleanliness and contamination control compliance
• Reviewed UAT scripts, system design specifications and functional documentation.
• Maintained traceability matrices ensuring requirement coverage across validation lifecycle.
• Managed test execution and defect tracking using qTest and JIRA.
• Collaborated with IT teams to validate SAP S/4HANA Quality Management modules.
• Participated in change control reviews through ServiceNow Change Management.
• Ensured compliance with 21 CFR Part 11 electronic records and electronic signatures requirements.
• Supported QA audits and validation deliverable reviews.
• Coordinated with cross functional teams including QA, IT, and Manufacturing stakeholders.

CQV Engineer - ResMed - San Diego, CA

(2021-03 - 2023-08)

Supported commissioning, qualification, and validation activities for medical device software platforms used in respiratory therapy products.

• Executed Commissioning, Qualification and Validation (CQV) activities for medical device software systems.
• Developed IQ, OQ, PQ protocols and executed validation testing.
• Conducted risk based validation aligned with GAMP 5 and FDA medical device regulations.
• Reviewed design specifications and software requirement documents.
• Supported test case development and UAT coordination with product teams.
• Ensured compliance with FDA 21 CFR Part 11 and ISO 13485 requirements.
• Assisted in defect tracking and test execution using JIRA and XRAY.
• Supported validation documentation reviews and approvals with QA leadership.
• Assisted during internal and external regulatory audits.

Validation Analyst - Laurus Labs Limited - India

(2018-06 - 2020-12)

Validated laboratory systems used for pharmaceutical quality testing and regulatory reporting.

• Assisted in validation of LabWare LIMS and laboratory applications.
• Prepared validation documentation including URS, test scripts and traceability matrix.
• Executed IQ/OQ/PQ testing for laboratory systems.
• Assisted in cleaning validation activities for laboratory and manufacturing equipment
• Participated in sampling (swab/rinse) and documentation of cleaning validation studies
• Reviewed test scripts and defect reports during UAT execution.
• Maintained compliance with GxP and FDA regulatory standards.
• Assisted in change control validation activities.
• Supported validation documentation preparation for QA review.

Master - Computer Science - University of Central Missouri

Bachelors - Electronics and communication Engineering - SRM University