SUMMARY:

• Over 5+ years of experience in executing protocols developing, implementing, and monitoring various quality programs for pharmaceutical, medical device, and ISO certified companies. Proven track record of consistent quality and reliability in carrying out activities as part of a high - performance team following business and regulatory requirements and guidelines.
• Knowledge of FDA Good Manufacturing Practices (GMP), Good Document Practices (GDP), 21 CFR FDA’s guidelines on Validation, Design, Risk Management and other applicable standards
• Comprehensive understanding of Design History File (DHF) and associated remediation activities
• Certified Six Sigma Green Belt, execution and monitoring of continuous improvement activities using Lean Manufacturing and Six Sigma disciplines & Design of Experiments (DOE)
• Worked with RCA investigational tools like 8D, Fishbone diagram, Pareto Chart, and Weibull Analysis for collected data.
• Experienced in Validating Computer Systems by authoring Validation Master Plan (VMP), Installation Qualifications (IQs), Operational Qualifications (OQs), Performance Qualification (PQs) and Validation Summary Report (VSR).
• Proficient in Risk Analysis PFMEA/DFMEA, ISO 14971 incident investigation RCA and CAPA
• Enhanced process parameters to improve production line efficiency with reduced labor hours, KPI factors
• Exposed to FDA - regulated medical device manufacturing - 21 CFR 820, ISO 9001, 13485, 14971, IEC 60601
• Conducted Gage R&R Studies, risk-based sampling using MiniTab and MSA studies on test equipments
• Used GD&T and ASME Y14.5M standards to communicate designs with manufacturers
• Competent user of design and modelling software - SolidWorks, AutoCAD
• Excellent written and verbal communication skills, team player with proven record of team management and leadership

TECHNICAL SKILLS:

Software & Tools: MS Office, SolidWorks, AutoCAD, ANSYS, ERP SAP, MATLAB, C, Fusion360, MS Excel, Unigraphics, Hyper mesh, Pro E, Wind-chill, Minitab, CAFTA, Weibull++, BOM, xFMEA, CATIA V5, eQRMS, Veeva, CelDox, DOORS, JAMA, Trackwise

PROFESSIONAL EXPERIENCE:

Sr Validation Engineer

Confidential

Responsibilities:

• Responsible for Validation Schedule of Multiple GMP facilities such as Filter Integrity Testers, BEMS, Temperature mapping including lifecycle activities such as Validation Plan, URS, Config Specs, IOQ and PQ/UAT protocols, validation executions
• Validation packet execution including SRC, system backup and resolving protocol related deviations in a timely manner.
• Manage project schedule for equipment commissioning and qualification for new systems and software upgrades by conducting cross functional team meetings with Delivery, Operations, QC and QA
• Documented reports for installation qualification, operational qualification and performance qualification validation protocols (IQ, OQ, PQ) in agreement to FDA standards.
• Routed Protocol and Validation related deviations in eQRMS, categorized the deviation for severity classification, identify the cause and write summary report for timely approval and validation of different Computer Systems.
• Validated pharmaceutical computer systems, manufacturing facilities and packaging and process equipment at client site following FDA, GxP, and 21 CFR Part 11 regulations.
• Reviewed and approved the site Computerized Systems Validation documentation and change controls from a CSV technical perspective.
• Led the development of data integrity risk assessments for lab systems for QC and Manufacturing labs as part of the Devens Data Integrity Program.
• Wrote documentation for all aspect of the computer systems validation lifecycle, in accordance with FDA regulations, particularly 21CFR Part 11.
• Validate test methods and processes utilized in the manufacturing of drug products, API’s including FDA 21 CFR Part 820 compliance and ISO 13485, 14971.
• Performed gap assessment on validation activities and provided improvements.
• Issuance of Batch Records, forms and related documents following compliance of SOP's and c GMP's.
• Maintained the Requirement Traceability Matrix (RTM) to gauge the progress on a regular basis.
• Developed traceability matrices, user requirements specifications, technical specifications, and functional specifications to create a serialization solution to fit a client's needs
• Provide clients with proven strategies and solutions for maximizing the value of good design, documentation, and data, as well as ensuring system compliance and data integrity.
• Authored URS (User Requirements Specification)/ FRS (Functional Requirements Specification) document and reviewed DS (Design Specification) documents.
• Develop and execute Decommissioning Protocols to retire GMP analytical equipment.
• Participated in all the phases of SDLC with GAMP 5 risk-based approach and involved in creating Validation protocols.
• Hands on experience in Quality Center, writing Requirement Traceability Matrix, SOP’s, Work Instruction.
• Developed test plans, test strategies, test scripts for validation testing along with the Test Summary Report.
• Involved in designing procedures and test methods which comply with business, FDA and industry best practice guidelines: FDA's 21 CFR210, 211 and 11; ISO 14971 and 13485, GMP and GAMP 5
• Lead team to perform external standards gap assessment to ensure products are meeting regulations and compliance.
• Analyzed Test Scripts impact on GxP environment to check if it has covered functionalities in all cases like development, testing and production phases, which need to be in compliance with 21CFR Part 11 rules set by FDA.
• Provided quality oversight to computer system validation programs, inclusive of validation plans, schedules, periodic reviews, and operational activities in alignment with the computer system validation lifecycle process.
• Managed traceability between requirements, design elements, and test cases in HP ALM.

Confidential (Minnetonka, MN)

Manufacturing/Quality Engineer

Responsibilities:

• Involved in new production equipment, process improvements and cost reductions while supporting new product introductions. Provide guidance to other engineers and technicians.
• Manufacturing Process Change for a VF04 catheter shaft which involved reduction of mandrel length and proposed reduction in excess material that is discarded
• Conducted multiple rounds of feasibility testing with variable length of mandrels and parts for additional cost reduction opportunities
• Performed cost analysis and determined material cost savings of 80,000$ with an upfront tooling cost.
• Identifies the scope of change for manufacturing process which includes recipe change at Automation HMI, new part numbers for raw materials, add annotation to existing drawing, EP design change and reverification meeting with Irvine Team.
• Worked on SDDP deliverable which defines the strategies, responsibilities to ensure compliance with European Union Medical Device Regulation (EU MDR 2017|745) for self- of Advisory SE cables and Flexibility SE cables
• Perform Process Validation/Verification (including MVP/MVR) revision and update PFMEA content as needed.
• Assess family documentation for Design Verification and perform necessary DV testing to support product requirements that are modified/created as a part of SDDP.
• Work with Regulatory and Quality Departments to ensure that design and test specifications for the system meet or exceed all applicable regulatory and quality standards. Meet international norms of medical devices like IEC 60601-1, Electro Magnetic Compatibility IEC 60601-2 and Risk Analysis ISO 14971
• Identify EU/MDR regulatory requirements and remediation gaps in Quality documentation, and review inefficiencies in the CAPA and NCR process, propose actions to support continuous improvement activities.
• Prepared and revised manufacturing process steps in support for product design changes in the VF04 catheters. Revised Design History File (DHF) remediation documents to reflect manufacturing changes for Regulatory submissions and compliance with EU MDR updates.
• Proposed batch size increase for catheters and cables on the manufacturing floor under Kaizen CIP project to have better shipper and pallet optimization to save on sterilization and logistics cost.
• Implemented batch size change on multiple catheter product lines in accordance with our current shippers’ configuration and achieved $150K yearly cost savings in line with our 2022 LBE numbers
• Proposed tray redesign and ordered protypes for accommodating increased batch size, worked with suppliers on finalizing the design and quote.
• Create and manage engineering change requests (ECR) and orders (ECO) for timely submissions in Windchill
• Worked in cross functional team for tray redesign, material selection and moving a ring brazing station within the manufacturing layout, which requires IQ, EDR study and getting new hose/electrical connection with the help of facilities.
• Performing projects which include new production equipment installation and qualification, process improvements, yield improvements, and cost reductions while supporting daily production activities.
• Collecting and analyzing in process data to evaluate capability and determine areas for process improvement.
• Driving process improvements and validations through manufacturing implementation and update pFMEAs and master validation plan as required. Author process validation protocols and reports. Including but not limited to equipment IQ, process OQ, process PQ, and product PPQ.
• Work with cross-functional teams to transfer new products efficiently and effectively into manufacturing.
• Work with various internal and external organizations to optimize manufacturing processes or resolving technical issues w/ on-going products or new products.

DHF Remediation Engineer

Confidential (Peepack, New Jersey)

Responsibilities:

• Development of design controls and DHF files including FMEAs and research reports to remediate combination products that were filed as a drug and have no Design History File for the device constituent part.
• Develop Technical Studies, Risk Analysis, Process Mapping, DOE's, Gap Analysis, Statistical Rationales, Discrepancy Reports, among other documentation.
• Responsible for Customer Complaint Investigations, Pre and Post market summary reports and Continuous Improvement projects, Quality Systems Excellence among other projects.
• Worked on revisions of uFMEA, DFMEA and pFMEA by effectively capturing user needs, design constraints, process inefficiencies and Hazard Analysis to ensure full proof safety.
• Assisted in investigations associated with Out-of-specification (OOS) and Non-conforming material reports (NCMR), Deviations, CAPA, Supplier Corrective Action Reports (SCARs)
• Authored Project Initiation Document (PID), User Requirement Specifications (URS), Product Requirement Specifications (PRS) documents.
• Applied quality engineering practices and guidance to support project team operations using Six Sigma tools, FMEA, Cause & Effect Matrix, DOE and Control Plans.
• Developed and updated the Trace Matrix to track requirements to ensure compliance with FDA regulations and quality review.
• Reviewed and approved all the quality documents: quality procedures, Standard Operating Procedures (SOP’s).
• Independently provide comprehensive technical solutions for issues related to quality processes, procedures and systems to meet organizational and regulatory objectives.
• Utilized statistical methods, such as, process capability data analysis, statistical process control (SPC), sample size and frequency selection to ensure processes capability and repeatability.
• Work in collaboration with sister-sites and suppliers to get the information needed to author the required DHF documents.
• Work with collective feedback from cross functional team, to ensure compliance with company quality systems, with inputs from Design Lead, Quality Assurance, Project Lead, Regulatory affairs and assure the necessary deliverables/process are in line with FDA regulations and quality review.

Validation Engineer

Confidential

Responsibilities:

• Developed FMEA and data integrity risk assessment for the company quality systems with inputs from validation, IT, and QA.
• Performed GAP Analysis for 20 Lab Systems including chromatography, spectrometers, statistical and imaging systems.
• Executed GAP Assessment Checklist, identifying risks in terms of data, vendor support, system access, audit trails, reprocessing, configuration, backup and data review & reporting.
• Conducted multiple team meetings with SMEs and System Owners to discuss critical data integrity steps in procedure and worked on mitigating risks through technical and procedural controls.
• Authored Test Scripts, Risk Assessment and System Design Documentation for system upgrade for an existing system with the help of collective feedback from cross functional team.
• Responsible for process evaluation and identifying risks relating data integrity for Lab Systems after meeting System Admins, Validation Lead, Information services and participating in Lab Demonstration of Instruments.
• Responsible in formulating Data Process Mapping, an attachment to SOP for instructions on steps to be followed by technicians.
• Documented reports for installation qualification, operating qualification and performance qualification validation protocols (IQ, OQ, PQ) in agreement to FDA standards.
• Implemented and managed Functional design requirements, design input and output (I/O), design Verification and Validation (V&V) and design risk management.

Validation Engineer

Confidential

Responsibilities:

• Responsible in developing Computer Systems Validation Methodology for category 5 equipment, following FDA Regulations and GAMP 5, such as Standard Operating Procedures, Site Validation Master Plan, templates and s.
• Performed the complete Qualification Package including Validation Master Plan (VMP) and Validation Protocols (IQs, OQs, and PQs) in detail and incompliance with 21CFR Part11.
• Performed method validation gap assessment against regulatory requirements including ICH, USP monograph and other FDA requirements.
• Coordinate and perform validations on equipment and process such as autoclaves, depyrogenation ovens, aseptic processes, product assembly lines, filling machines, sterilization processes, and cleaning processes in laboratories, clean rooms, and production floors
• Processed and approved batch records, test methods and related GMP documents using CATSWeb
• Analyzed and reviewed validation deliverables like Validation Plan, Risk Assessment, Validation Summary Report in compliance with 21 CFR Part 11, GAMP 5 and GMP FDA Compliance
• Validated applications like Laboratory Information Management System (LIMS), TrackWise, Document Management System (EDMS), in compliance with FDA regulations.
• Gap Assessment-Reviewed and composed documentation for remediation of equipment and utilities gaps in existing qualification documentation and the new Commissioning and Qualification program
• Developed Standard Operating Procedures and validation testing to meet CFR Part 11 and Data Integrity requirements for analytical equipment.
• Development of policies and procedures for Computer System Validation Lifecycle management.
• Successfully performed the quality system gap assessment and created the quality plan for establishing quality management systems in accordance with FDA QSR and ISO 13485:2016
• Designing procedures and test methods which comply with business, FDA and industry best practice guidelines: FDA - 21 CFR 11; ISO 14971 and 13485, GMP and GAMP 5.
• Revised current SOPs to align with changes to company Quality Systems; also developed an internal tracking tool for managing revisions to relevant industry standards and wrote associated SOP for implementation/maintenance.
• Performed risk assessments for data integrity and 21 CFR part 11 assessments of any firmware/software's related to tablet tester, particle size analyzer.
• Extensively used SQL statements to query the Oracle Database for Data Validation and Data Integrity.
• Guide IT team on Good Documentation Practices (GDP) related to cGMP and other regulatory requirements.
• Wrote IQ, OQ and PQ and developed Data migration protocols and conducted the dry run in Quality Center.
• Developed Detailed Risk Assessment documentation for managing the risk levels used before validation the system.
• Developed Trace Matrix document for mapping the URS, FS, DS (Design Specification), IQ, OQ and Conducted reporting and tracking of defects using Quality Center.

Process Engineer/ Quality Control

Confidential

Responsibilities:

• Process Monitoring in clean room, high vacuum environment for bust bar, photo resist and Index matched ITO coating.
• Structured sequence of operations (SOE/SOP) and drafted work instructions (WI) and process/quality audit sheets
• Managed customer orders and operations for various activities such as cleaning, itching, beveling, photomask and coatings.
• Worked in product failure analysis, DHF/FMEA assessment, Risk Management (ISO 14971), CAPA, process improvement.
• Quality Control/Assurance for high performance medical devices, semiconductors, display and R&D applications.
• Reviewed and approved all the quality documents: quality procedures, Standard Operating Procedures (SOP’s).
• Conducting Process Capability Study, Test Method Validation, DOE, SPC and transfer of batches from R&D to production
• Troubleshooting high vacuum pump, calibration of ion beam gun and optical monitor for chemical vapor deposition.
• Provided support to Maintenance and technicians to develop preventive and predictive maintenance
• Standardized hardware and tools across the factory and sunset inventory to lean manufacturing
• Adjusting Peaks and baselines for result reporting according to client needs.
• Analysis and Simulation of Rotorcraft Components - Conducted fatigue, failure and crash tests on using DFMEA, analyzed parts using Altair HyperMesh in Optistruct and RADIOSS module
• Development of monitoring in wing flaps - Implemented knowledge of nano-materials, MEMS to develop structural health monitoring to automatically detect deterioration in structure and report defects through sensor.
• Modal and Buckling analysis of sheet metal, plastics and BIW components using Altair HyperMesh. Considered Finite Element Analysis (FEA), design considerations, PLM and generated BOM for parts and assemblies
• Design and Analysis of Bike Towing Device - Redesigned device with improved performance using DFM concepts. Conducted finite element analysis, developed House of Quality (QFD), Product Architecture; feasible (30% cost reduction)

Mechanical Engineer Co-op

Confidential

Responsibilities:

• Worked on system safety requirements from customer and translating them into subsystems and component level requirement
• Achieved accurate failure causes for electro-mechanical systems reliability and safety by conducting root cause analysis.
• Assisted the team with design change using SolidWorks, ECO, electrical schematics, testing, documentation and system development of the ongoing Boeing 777X and A350 programs.
• Conducted analysis on customer returned products as a part of Lean Process Improvement initiative, identified potential trends and failures, customer complaints, conducted statistical analysis and presented it to cross functional team.
• Assisted the lab team in Qualification test procedure, environment testing of the actuators, troubleshoot equipment and help maintain and improve quality.
• Assisted the systems safety team with FMEAs, Fault Tree Analysis using CAFTA, hazard, safety and risk analysis documentation
• Process validation support for Boeing 777X Rudder Pedal to comply with the system and airplane level requirements.

Validation Engineer

Confidential

Responsibilities:

• Worked with the team in Project Planning, organizing, and maintaining the traceability between requirements and risk management activities.
• Involved in project management and product life cycle management of the design process.
• Assisted in developing/execution oftestmethodvalidation (TMV), and Gage R&R studies
• Reviewed the BOMs and qualified the vendors and suppliers.
• Focus on design input, design output, design verification, design validation and design transfer activities.
• Reviewed test methods (TM) and design verification test plans.
• Provided quality input to project design controls and Failure Modes Effects Analysis (FMEA).
• Established quality measuring parameters, including attribute and variable analysis with GD&T, SPC charting, gauge R & R, process capability studies and analysis with Cpk/Ppk measurements.
• Revised the Standard Operating Procedures (SOPs) and Design History Files (DHF).
• Generate process/product quality information in the form ofCritical to Quality (CTQ) indices and share with project team/operations recommendations and solutions to emerging issues.
• Improve key quality metrics (First Pass Acceptance, Quality Notifications and Complaint data).
• Develop Design / Device History Files and maintain in a manner consistent with FDA requirements.
• Ensure robust execution of the design verification, validation, risk management, and process validation activities (IQ/OQ/PQ) executed for all aspects of product development and Change Control activities.