Amala

Validation Engineer with 5+ years of experience in Computer System Validation (CSV), equipment qualification, and quality assurance within FDA-regulated pharmaceutical and medical device environments. Proficient in FDA 21 CFR Part 11, 210, and 211, GAMP 5, EU Annex 11, and Software Development Life Cycle (SDLC) validation processes. Skilled in authoring and executing Validation Plans (VP), Master Validation Plans (MVP), User Requirement Specifications (URS), IQ/OQ/PQ protocols, and Requirement Traceability Matrices (RTM).

Experienced in CSV of LIMS and document management systems, GMP/GLP/GCP compliance, risk assessment, CAPA, and change control. Proven track record partnering with cross-functional Quality, Manufacturing, and Regulatory Affairs teams to support audit readiness and regulatory compliance.

Quality Engineer - Regeneron - New York, NY

(2024-03)

• Manage process validation activities for infusion pumps and automated drug delivery systems, ensuring compliance with FDA, ISO 13485, and cGMP requirements.
• Author and execute IQ/OQ/PQ validation protocols for Document Management Systems and manufacturing equipment, incorporating design tolerances into test plans and variation analysis.
• Perform gap analysis of equipment calibration processes against AS9100 standards; implemented corrective actions that reduced calibration-related non-conformances by 15%.
• Integrate CAD data with PLM systems (Windchill, Teamcenter) to streamline change management and design documentation workflows.
• Developed, executed, and maintained electronic validation documentation using Kneat Gx, including URS, Risk Assessments, IQ/OQ/PQ protocols, validation reports, deviation management, and audit-ready documentation in compliance with cGMP and FDA regulation
• Develop and execute IQ/OQ/PQ validation protocols for CNC machines and associated tooling systems supporting precision manufacturing.
• Support installation, commissioning, and qualification of new manufacturing equipment and production lines, partnering with cross-functional teams to ensure production readiness.
• Establish and enforce Design Controls across the product lifecycle, ensuring full traceability and audit-readiness for FDA inspections.
• Plan, author, and execute Design Verification (DV) and Design Validation (V&V) protocols and reports in accordance with FDA Design Controls and ISO 13485.
• Author and maintain Design History File (DHF) documentation, including verification protocols, Requirement Traceability Matrices, and validation reports.
• Analyze verification and inspection data using Minitab, applying DOE, process capability, and trend analysis; execute MSA and Gauge R&R studies to qualify inspection methods.
• Collaborate with R&D, Manufacturing, Regulatory Affairs, and Quality Engineering teams to harmonize verification methods across global product development programs.
• Author and review qualification protocols, URS, SOPs, and validation reports supporting equipment startup and regulatory compliance.
• Design and implement a CAPA metrics dashboard to track trends and provide executive-level visibility into quality performance.
• Support the transition to Industry 4.0 capabilities in injection molding, including sensor-based process monitoring and automated data logging.
• Audit quality processes in accordance with ISO 9001, AS9100, and ISO 13485 standards to ensure regulatory and industry compliance.

Quality Engineer - Viatris - Pittsburgh, PA

(2023-03 - 2024-02)

• Oversaw Design Control activities throughout the product lifecycle, ensuring compliance with FDA regulations, ISO 13485, and ISO 14971.
• Developed and executed validation strategies for diagnostic medical devices to support regulatory compliance and product reliability.
• Executed IQ/OQ/PQ protocols for diagnostic and laboratory equipment, confirming devices met functional and performance specifications for regulatory approval.
• Collaborated with cross-functional teams to implement DFMEA and PFMEA, mitigating design and process risks.
• Revamped validation documentation workflows, increasing efficiency by 20% without compromising compliance or quality.
• Performed equipment qualification and calibration assessments to ensure regulatory compliance and operational reliability.
• Investigated quality deviations, identifying root causes and implementing corrective actions that improved product safety and compliance.
• Led execution of verification tests, validating product designs against user requirements and regulatory expectations.
• Executed Design Verification (DV) and Design Validation (V&V) activities, including requirements traceability, protocol execution, and validation reporting.
• Collected and analyzed verification test data using statistical methods to support product qualification and regulatory submissions.
• Collaborated with manufacturing and R&D teams during design transfer to validate manufacturing test methods and improve production readiness.
• Conducted statistical analysis of verification results using Minitab to support engineering decisions and regulatory documentation.
• Performed Measurement System Analysis (MSA) and Gauge R&R studies to verify inspection system accuracy and repeatability.
• Managed the design transfer process, ensuring seamless transition of products from development to manufacturing while maintaining quality standards.
• Contributed to audit preparation, ensuring documentation accuracy and compliance for internal and external regulatory inspections.
• Conducted risk assessments on critical components to reinforce product reliability and regulatory compliance.

Validation Engineer - Sun Pharma - India

(2021-05 - 2022-09)

• Executed IQ/OQ protocols for HVAC systems supporting production of ECGs, defibrillators, and patient monitors.
• Prepared qualification documents for equipment used in infusion pumps, oxygen concentrators, and anesthesia workstations.
• Conducted GA drawing walkdowns and P&ID reviews for HVAC and utility systems in imaging device manufacturing areas (ultrasound, C-arms).
• Performed filter integrity testing to maintain clean air standards for fetal monitor and colposcope manufacturing.
• Verified purified water line slopes to ensure GMP compliance for ventilator and nebulizer production.
• Documented and resolved deviations during qualification of cardiology and critical care device manufacturing equipment.
• Identified and escalated validation risks to senior engineering leadership, recommending and implementing mitigation strategies to maintain project timelines and compliance.
• Created and executed qualification protocols for consumables, including ECG electrodes and syringe pumps.
• Managed GMP change controls for systems supporting surgical diathermy and weighing scale manufacturing.
• Conducted risk assessments for processes and equipment across diagnostic X-ray, home care, and accessory device manufacturing.

Master of Science - Business Analytics - University of New Haven

Bachelor of Technology - Electronics & Communication Engineering - Geethanjali College of Engineering and Technology