SUMMARY

• Around 7+ years’ experience as Validation Engineer/Quality and (CSV) with experience in Manufacturing and medical device environment.
• Strong background in Commissioning, Qualification,Validationsand Quality. Knowledge in FDA, GMP's, GAMP5, GxP, CSV,MES, ERP, Lab equipment and PLC.
• Well versed with equipments and fixtures - Injection Molding and automated assembly lines.
• Reviewed protocols for completeness, cGxP compliance, and compiled final validation package.
• Executions, validation summary reports and DHF remediation for medical devices and components.
• Diversified skills include project management, Microsoft Office, CAPA, SCAR, IQ/OQ/PQ qualification, SOP writing, URS writing. Experienced medical device manufacturing requirements (FDA-GMP, ISO 9001).
• Experience in utilities and facilities qualification, equipment qualification, and computer validation
• Created & Maintained the Master document list, which constitutes thevalidationpackage.
• Extensive experience in FDA 21 CFR Part 11, CFR 211/210validation, performing Gap analysis, Remediation Plan, SOPs,Validation Protocols, Technical Writing, Quality Assurance, AutomatedTestTools andTestcases and Corrective and Preventive Actions (CAPA).
• Survey and endorsement of approval documentation back venture and framework reviews and inspections
• Guarantee in general framework quality through early deviation discovery and hazard management
• Maintain knowledge information of inner and outside directions relating to GxP framework approval inside the pharmaceutical division
• Shape and give input to approval approaches for ventures in pharmacovigilance zone.
• Experienced with transfer new product tomanufacturingandProcessimprovement, Equipment Validation and Qualification (IQ/IQ/PQ).Supplier Corrective Action Report (SCAR) and Scorecard experience while working with the Material Review Board (MRB).
• Performed test method validations (Gage R&R studies - Minitab). Statistical Data Analysis Experience using Minitab.Strong knowledge about Medical device regulations like FDA: 21 CFR Part 11, 21 CFR Part 58, 21 CFR Part 210, 21 CFR Part 211 and 21 CFR Part 820.
• Expert background of Software Development Life Cycle (SDLC) and Validation Life Cycle (VLC). Familiar with Technology transfer (TT), Waterfall, Agile, and V-model. Expertise in writing Installation Qualification (IQ) protocol, Operational Qualification (OQ) protocol, Performance Qualification (PQ) protocol and Standard Operating Procedures (SOPs).
• Extensive experience in developing Test Plan, Test Cases and Test Summary Report.
• Involved in authoring and executing temperature mapping protocols and summary reports for Refrigerators, autoclaves, oven's and Freezers using Val probes.
• Experienced with temperature and relative humidity mapping studies for equipments, ISO cleanrooms and facilities (warehouses) validation using calibrated temperature / RH% data loggers and Kaye Valprobes

TECHNICAL SKILLS

Operating Systems: Unix, Win200X/XP/NT/7, and Linux

Validation: FDA Quality system regulations, protocols (IQ, OQ, PQ) cGXP (GLP, cGMP), Standard Operation Procedures (SOP), LIMS, AERS, Gap Analysis, GAMP 4, GAMP 5, ITIL, RTM, Audit Trials, Remediation, Track Wise

Tools: MS Office (Word, Excel, PowerPoint, Access, Documentum, Quick Test Pro, SharePoint.

SDLC/Methodologies: Waterfall, Agile.

PROFESSIONAL EXPERIENCE

Confidential, Buffalo Grove, IL

Sr. Validation Engineer

Responsibilities:

• Excellent working information of Computer Framework Approval (CSV), creating and looking into Establishment Capability Installation Qualification (IQ), Operational Capability (OQ) and Execution Capability Performance Qualification (PQ).
• Wrote Protocol - Report for Affirmation consider, Pre IQ, OQ, PQ.
• Review and Favor all documentation to guarantee Company Approaches and Directions are met.
• Experience utilizing persistent advancement apparatuses, such as FMEA, Control arrange, Root Cause Analysis.
• Executed CAPAs/NCRs related fabricating Nonconformances, field complaints.
• Creation/ Overhaul of Ace Approval Arrange and other Approval records for existing products.
• Drafted Approval Arrange (VP), drafted and executed Establishment, Operational Capability and Execution Capability Protocols.
• Dynamic support within the crevice analysis, checking for archives within the framework and making unused reports for Test Strategy, Test Strategy conventions and Approval Reports.
• Performing and archiving capability and approval testing metrology equipments Coordinate Measuring Machines (CMM) and Vision Coordinate Measuring Machines (VCMM).
• Performed Temperature Mapping Studies using Kaye validator 2000 to document the thermodynamics of specific area.
• The Project Involved in, Qualification and Validation of Manufacturing and process equipment, qualification of clean rooms and temperature mapping of Cleanrooms and Warehouses.
• Performed Temperature Distribution and Heat Penetration Studies on Oven by using Kaye Validator AVS Version 1.

Confidential, Gurnee, IL

Validation Engineer

Responsibilities:

• Created Equipments Validation protocols and reports for COVID-19.
• Drafted Equipment Qualification Protocols usingValidationMaster Plan (VMP), User Requirement Specifications (URs), Functional Design Specifications (FDS) and Equipment Manuals.
• Responsible for supporting manufacturing for development process activities such as process for COVID-19 test kits and equipments validation and qualification (IQ/OQ/PQ).
• Provided validation support by applying manufacturing quality tools like FMEA, DFMEA, OQ, PQ, control plans.
• Managed, executed and documented the qualification and validation of equipments, processes, and manufactured components to meet the requirements of U.S. government.
• Excellent working experience on COVID-19 test kits equipments such as Closer Tape Dispenscers, Band Sealers, Lable Applicators, Test Strip Dispencers, QuickPouch Micro, Leak tester PTI (Packaging technology and Inspection), Webview- Automated Web Inspection Vision System.
• Validated more then 600 equipments in a one month to expedited the production process.
• Performed test method validations (Capability studies - Minitab). Statistical Data Analysis Experience using Minitab.
• Improved packaging-related engineering changes to meet customer requirements and improve production efficiency.

Confidential, Buffalo Grove, IL

Manufacturing Validation Engineer

Responsibilities:

• Excellent working knowledge of Computer SystemValidation(CSV), developing and reviewing Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
• Wrote Protocol-Report for Confirmation study, Pre IQ, OQ, PQ.
• Review and Approve alldocumentation to ensure Company Policies and Regulations are met.
• Experience using continuous improvement tools, such as FMEA, Control plan, Root Cause Analysis.
• Executed CAPAs/NCRs related manufacturing Nonconformances, field complaints.
• Creation/ Update of Master Validation Plan and other Validation documents for existing products.
• DraftedValidationPlan (VP), drafted and executed Installation, Operational Qualification and Performance Qualification Protocols.
• Active participation in the gap analysis, checking for documents in the system and creating new documents for Test Method, Test Method protocols and Validation Reports.
• Performing and documenting qualification and validation testing to accommodate process changes for existing product lines.
• Facilitating/participating in FMEA’s for existing production processes.
• Providing Support and implementing preventive actions and control plans to adequately address the FMEA result.
• Provided validation support by applying manufacturing quality tools like FMEA, DFMEA, OQ, PQ, control plans.
• Worked on project CAPA investigation and resolution teams, overall risk analysis and in process PFMEA (Process Failure Mode and Effects Analysis).
• Applied quality engineering practices and guidance to support project teams and manufacturing operations using Six Sigma tools, FMEA, Cause & Effect Matrix, DOE and Control Plans.
• Utilized statistical methods, such as, process capability data analysis, statistical process control (SPC), sample size and frequency selection to ensure processes capability and repeatability.
• Developed and updated assembly procedures to be more efficient and ergonomic.
• Excellent working knowledge with measuring OGP (Optiical Gaging Products), CMM (Coordinate measuring machines) and Cognex vision system.
• Performed Temperature Distribution and Heat Penetration Studies on Oven by using Kaye Validator AVS Version 1.2.
• Reviews and writes Final Reports to complete the protocols
• Prepared Binder for the Depyrogenation Oven, Refrigerator IQ/OQ/PQ Protocols.
• Peer reviewed the IOPQ Protocol and Summary Report for the Refrigerator.
• Drafted, Authored and executed IQ/OQ/PQ Protocol for Warehouse Temperature Mapping.
• Performed Temperature and Humidity Mapping for empty Warehouse, Microbiology Lab and SMT Area by using Kaye Val probes.
• Authored Final Summary Report of Thermal Mapping of Empty Warehouse temperature mapping Microbiology Lab and SMT Area.
• Authored Deviation Reports for the Warehouse temperature mapping and cleanrooms.
• Drafted and Authored IQ/OQ/PQ for the Refrigerator Solder Storage Paste.
• Authored and Executed the Protocol for Dickson one Temperature Alarm Verification
• The Project Involved Commissioning, Qualification and Validation of Manufacturing and process equipment, qualification of clean rooms and temperature mapping of Rooms and Ovens.
• Responsible for developing, Authoring and executing Validation Protocols for Equipment, Facilities and utilities at the manufacturing facility.
• Executed Validation Protocols and performed temperature mapping studies for Ovens, Refrigerators and Clean rooms by using Data Loggers.
• Performed Temperature Mapping Studies for Autoclave using Kaye Validator 2000.
• Performed validations activities (SAT, and IQ/OQ/PQ) for automated E-Beam Sterilization process.
• Updated user requirement specifications (URS) and validation Plan (VP) and Interim Sterilization Validation report for Sterilization.
• Provided packaging support to clients’ brand products and consumable devices prodcuts.
• Developed packaging design specifications for components and consumable products of the clients.
• Coordinated development and validation of new packaging tooling.
• Troubleshot production packaging processes and recommended improvements to streamline productivity.
• Managed packaging project, maintained and scheduled projects and its resources.
• Implemented new process and automation project and ensured that all deadlines were met and it was within prescribed budget.
• Analyzed packaging process and recommended all improvements that could be made to project.
• Prepared capital expenditure list and prepared requests for equipment and fixtures.
• Maintained an existing assets list and installed new equipment.
• Developed various projects for cost reduction of project and ensured that project was within budget.
• Supervised all installation and repair work that was carried and ensured that all goals for projects were achieved.
• Designed package product and specifications and prepared reports for process.

Confidential, EI Paso, TX

Validation Engineer

Responsibilities:

• Create Test Method (TM), Test MethodValidation(TMV), Test MethodValidationReport (TMVR), IQ, OP, PQ protocol documentation for Medtronics products to meet Corporate and FDA regulatory compliance using MS Word, Excel.
• Performed internal audit on drug safety reporting and Argus database validation protocols and reports to ensure compliance with cGMP, GAMP5, FDA, HIPAA, ICH, WHO, EMEA and NCA directives, such as 2001/82/EC, 2001/82/EC, 2004/726EC, etc. and Pharmacovigilance reporting through the EVWEB and MedWatch utilities.
• Involved in preparing documentation for all aspects of the computer system validation life cycle, in accordance with FDA design control and regulations, particularly 21 CFR 820.
• Support cGMP program including: Risk Analysis, Change Control, and Standard Operating Procedure using QUMAS. Support Site Expansion and Renovation activities including Commissioning and Qualification for Facility, Utility and Equipment related systems.
• Responsible for authoring, performing and/or approving qualification and validation documentation such as System Design Requirement Specifications (SDRS), Change Control, Document Change Notice (DCN), Non Conformance Reporting (NCR), GAP Analyses, CAPA, Process Failure Mode and Effect Analyses (PFMEA's), Engineering Studies (ES), Process Verification and Qualification, Design History Records (DHR), Protocols, SOPs and Test Methods.
• Worked to provide a secure and managing solution for Environmental Monitoring (EM) sampling for the Biological Quality lab Participated in internal and external audits including FDA and EMEA
• Performed design verification pertaining to device QMS ISO 13485, 14971 for risk management.
• Create Process Flow Diagrams (PFDs) to illustrate the manufacturing process of medical devices using Visio.
• Managed, executed and documented the qualification and validation of equipment, processes, and manufactured components to meet the requirements.
• Execution of development study and validation protocols which involves mock soiling of product contact surfaces, operation of equipment for cleaning procedure, collection of rinse water samples for bioburden, endotoxin and TOC testing, visual inspection and collection of swab samples.
• Loaded IQ, OP, PQ, TMV documents into PDM (Product Data Management) system, (a controlled document/data management system) for review and approval signatures.
• Assessed failure of previous implementation of Product Development Process program for this manufacturer of Medical Devices and Instruments.
• Create and execute Controlled Temperature Unit (CTU) Validation protocols. Write deviation investigation, impact assessment and resolution if unit fails to meet acceptance criteria.
• Provide training documentation using MS PowerPoint, Word and Visio.
• Performed Design of Experiments (DOE). Determined manufacturing process limit requirements and processing parameters to qualify/validate processes. Documented process data to verify repeatability, reproducibility and specifically, requirements based on intended use.
• Review tools for LIMS decision support to be used by the site. Analysis of LIMS enhancements, troubleshooting issues, second tier application support and routine master data configuration as required within the LabWare LIMS application.
• Performed an investigational lifetime study on the released medical device to determine and ensure functional and lifetime requirements are met. n qualification/validation activities to 21 CFR, Parts 11 and 820, along with QMS ISO-13485.
• Support technology transfer activities, process/ software characterization studies and gauge R&R studies within the Manufacturing Process.
• Responsible for supporting manufacturing for development process activities such as process and equipment validation and qualification (IQ/OQ/PQ).
• Initiated technical specification modifications to improve plant productions and efficiency.
• Monitored quality inspections for performance of a molding supplier to ensure detailed specifications of the production.
• Assessed the quality of materials delivered by suppliers to ensure high quality of production of packaging products.

Confidential, Ann Arbor, MI

Manufacturing Validation Engineer

Responsibilities:

• Work with project/product managers to drive new products through the New Product Introduction (NPI).
• Developed Installation and Operational Qualification Protocols for Modified and executed Installation Qualification Protocols (General Installation, Maintenance, Health and Safety, Ergonomics, Utilities) and Operational Qualification Protocols (Functional Testing and Utility Failure) and drafted Exceptions (Deviations) for Smart Workbenches.
• Responsible for testing the operation ofmedicaldevices and perform maintenance ofmedical equipment.
• Revise and updateCSVSOP’s to maintain harmonization with Corporate Policies and provides training to the affected personnel.
• Review/Approve Process Validation for injection Molding processes for plastic components, SPC techniques and statistical data analysis.
• Conducted research to analyze equipment and system feasibility, design, operation and performance.
• Involved in the assessment of risk management activities throughout the lifecycle of all legacy products
• Function as site HACCP coordinator; complete risk assessments for process and product changes
• Provided validation support by applying manufacturing quality tools like FMEA, DFMEA, control plans, SPC.
• DraftedValidationPlan (VP), drafted and executed Installation and Operational Qualification Protocols for Bit Trays, Label Printers and G.P.Reeves Lubrication System, Pick-to-Lights and Kit Tray Mounting Station Readers (RFID Reader).
• Transferred to the set-up of tooling and injection molding machines to produce quality product.
• Drove supplier development by assisting them in developing problem solving control tools such as: 8D, process mapping, FMEAs, mistake proofing, SPC, Process Capability, Gage R&R, etc.
• Update commodities, bill of materials and labeling bill of materials for serialization.
• Conduct and implement label testing for serialization project.
• Developvalidationpackage(ValidationPlan, requirements, design, IOQ protocol) for thevalidation of color vision inspection system for a blister packaging machine.
• Drafted Equipment Qualification Protocols usingValidationMaster Plan (VMP), User Requirement Specifications (URs), Functional Design Specifications (FDS) and Equipment Manuals.
• Review and construct Risk Management Confirmation. Requires utilizing Surgical Technique guidelines, Design Failure Mode Effect Analysis (DFMEA), Package Insert and Label for current compliance.
• Coordinated with plastics engineer in planning the design of all flexible packaging materials.
• Established and organized product validations for internal clients’ material transfers.
• Worked with marketing staff in developing new low cost peelable films for packaging.

Confidential

Validation Engineer

Responsibilities:

• Designed procedures and test methods which comply with business, Regulatory, FDA, and industry best-practice guidelines: FDA 21 CFR Part 820 and Part 11, ISO 14971 and 13485, cGMP, GAMP4.
• Involved inauditingthe application for 21 CFR Part 11FDA 21 CFR part 820, IEC 60601-1, ISO 13485, and ISO 14971. Compliance related toElectronic SignaturesandElectronic Recordsfor Trackwise System.
• Excellent working knowledge of Computer SystemValidation(CSV), developing and reviewing Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
• Excellent working experience on Implantable cardioverter-defibrillator (ICD), Pacemaker, Mechanical heart valve sizer.
• Reviewed pFMEA (Process Failure Mode and Effect Analysis) to assess risk of equipment on process.
• CRO / supplier auditing, GMP GxP Document Auditing, Document Quality Review and Approval
• Developed validation documentation (Requirements; Design Specifications; Risk Assessment; IQ, OQ, PQ; RTM, and Reports) for manufacturing processes, systems, and equipment.
• Supervised and participated in the implementation of quality assurance procedures and test processes.
• Identified and assessed impact of Change Control activities for validated equipment, software, and systems.