Product Development Risk Management
Resume:
VIKAS YELLANKI
*************@*****.***
www.linkedin.com/in/yellankivikas
SUMMARY:
• Engineering Professional with more than Eight years of experience in Medical Device Industry, with in depth knowledge and strong base in Design Controls, Manufacturing, Quality Engineering, Product Line Transfer and Implementation, Process Validation, Test method validation & Equipment Qualification.
• Well - versed with applying the manufacturing quality toolset including PFMEA, Control plans, GR&R / MSA, GD&T, control plans, process verification/validation plans, validation protocol development, Cpk, Cp, SPC. Knowledge of new product development: Design Controls, Quality Planning, compliance including DHF/IDF, Verification and Validation, Risk Management, Process Validation (IQ/OQ/PQ) protocols and reports.
• Working experience in Orthopedic, Implantable devices, Electromechanical Devices.
• Implemented and maintained manufacturing-specific process controls, including statistical process control (SPC) and process capability analysis, to monitor and improve manufacturing processes within the manufacturing facility.
• Designed, programmed, and configured DeltaV, PLCs, and SCADA systems for industrial automation, ensuring reliable process control.
• experience in ITIL change management and SOPs supporting this process.
• Comprehensive knowledge of product development life cycle, risk assessment, and validation protocols.
• Authored Validation protocols for WFI system (Water Purifier).
• Preparation of SOP'S / Calibration / Process Validation / Validation Documentation.
• In-depth knowledge of the concepts of engineering change control, statistical techniques, and IQ, OQ, PQ validation protocols.
• Well-versed in the methodologies of software validation and verification, sterilization processes, and FDA (21 CFR 803/806/820).
• Experience in qualification of Tablet coater, air compressor, dryer, Refrigerators, freezers and temperature mapping using Kaye Validator.
• Extensive experience leading the areas of QA/QC, regulatory affairs, regulatory operations, regulatory compliance, quality software validation and verification and complaints analysis.
• Pharmaceutical Quality Manufacturing Current Good Manufacturing Practices (cGMP), Good Documentation Processes, Quality Systems Management, Regulatory Compliance, Corrective and Preventive Action Planning (CAPA).
• Well-versed in communicating effectively with knowledge of basic computer applications.
• Hands-on experience in testing quality of medical devices for various applications with sound knowledge of standard quality testing.
• In-depth knowledge of cGMP, regulatory, industry, and corporate guidelines and requirements.
• Support compliance with manufacturing system, Facilities Services Qualification Master Plan.
• Conducted comprehensive risk assessments per ISO 14971, identifying potential hazards and implementing risk control measures to ensure patient safety.
• Authored and maintained detailed risk management files and reports, demonstrating compliance with ISO 14971 for audits and regulatory submissions.
• Implemented risk management processes and procedures, continuously improving based on feedback and new regulations.
• Establish and maintain Equipment History Files (EHF).
• Experience temperature mapping of refrigerators, freezers, incubators, warm and cold rooms.
• Calibration of Thermocouples for Temperature Mapping Studies; experience with Kaye Validators.
• Experience in the Pharmaceutical industry and Medical Device Industry with emphasis on 21 CFR Part 11 and GXP regulations and around four years of experience on GAMP V principles/ Guidelines.
TECHNICAL SKILLS:
Statistical and
Design tools
JMP, Mini-tab, Solid Works, Creo, Hypermesh, MS Visio and Draft Sight. Manufacturing
Equipment
Lean Manufacturing, Continuous Improvement, Control Plans, Gage R&R, Risk Management, Six Sigma, Lean Manufacturing, Mini-tab, Process improvement, Continuous Improvement, Assembly, SPC, Process Validation, Risk Management, NCMR, SCAR, Process& Test Method Validations, Process Mapping, FMEA, Quality Control Plans, CAPA, Root Cause Analysis, Statistics, Quality Audits, SPC, new product development, CAPA, IQ, OQ and PQ in regulated environment & FDA compliance, Medical Devices. QA Work
Experience
CAPA, Manufacturing, advance technology, tool & fixture design, new product development, IQ/OQ/PQ in GxP regulated environment (Review and Approve) as per FDA compliance.
Software
Lab Ware LIMS v5, V6 and v7, Empower, Master Control. Technical Skills
TMV and IQ/OQ/PQ Validations, Lean/ Six, DFMEA, PFMEA, Root Cause Analysis, DHF remediation, Corrective and Preventive Action (CAPA). PROFESSIONAL EXPERIENCE:
Catalent Pharma Bloomington, IN SEP 2022 – PRESENT Sr. Manufacturing Engineer Responsibilities:
• Apply knowledge of process control tools, statistical sampling, and other analytical techniques to maximize the quality and flow of product through the production line.
• Documentation Control: Engineer Change Order, Create, Review and Approval Specifications, FMEAs, BHRS.
• Spearheaded the development and testing of medical device, ensuring compliance with industry standards and regulatory requirements.
• Responsible for maintaining Quality Hire System Regulations (Part 820) and Regulatory Standards (ISO13485/14971).
• Utilized SolidWorks, AutoCAD, and CATIA V5 to design and optimize facility layouts, equipment installations, and modifications, leading to a 15% increase in space utilization and workflow efficiency.
• Work with Production, Manufacturing/Process Engineering to create validation protocols, summaries and approvals to resolve process issues and implement changes.
• Designed and implemented safety systems using Rockwell Automation's GuardLogix controllers and Safety I/O modules. Developed safety programs adhering to stringent safety standards, ensuring the protection of personnel and equipment while maintaining high productivity levels.
• Programmed and configured control systems, including Rockwell Automation PLCs and DCS systems, to streamline production processes and improve efficiency.
• Integrated and configured Cognex and Keyence Vision Systems for automated inspection and quality control.
• Provided technical support and troubleshooting for PLCs, SCADA, and automation systems in a pharmaceutical manufacturing environment.
• Developed and tested medical devices to meet IEC60601-1 safety standards, ensuring electrical safety and performance under various operating conditions.
• Performed detailed safety analyses, including fault tree analysis and failure mode effects analysis, to ensure product compliance with IEC60601-1 and IEC61010.
• Executed system validation protocols (IQ/OQ) for PLC-based control systems, ensuring regulatory compliance and proper functionality across manufacturing processes.
• Programmed Human-Machine Interfaces (HMIs) for PLC applications, enabling real-time monitoring and control of industrial processes, improving operator interaction and efficiency.
• Implemented effective defect management strategies, tracking and resolving issues throughout the development lifecycle.
• Participated in and led design reviews, providing critical feedback to improve product quality and compliance with standards.
• Provide hands-on support and troubleshooting of manufacturing processes, tooling and equipment.
• Analysis and documentation in the management of material, manufacturing process updates, qualification activities, compliance activities, and CAPAs.
• Perform Equipment Installation, Manufacturing Process Characterization, Operational Qualification, and Performance Qualification (IQ/OQ/PQ) activities, as well as Software Validation and Test Method Validation for manufacturing equipment and processes.
• Created and executed testing protocols for medical devices, documenting results to demonstrate compliance with IEC60601-1 and IEC61010 safety standards.
• Generate all related documentation in compliance with internal and external requirements.
• Performed validation reports for the cleaning equipment in the manufacturing and packaging area.
• Risk Management: FMEA and fault tree analysis.
• Support and perform Quality Audits - Internal, External, FDA, BSI Regulatory Bodies.
• Provided engineering support for custom automation equipment for high-volume manufacturing in the medical devices industry. Experienced in troubleshooting automation equipment, process validation (IQ, OQ, PQ), and developing control plans.
• Involved in the installation and commissioning of new equipment, maintaining process FMEAs, and collaborating with various stakeholders to troubleshoot process and equipment issues.
Edwards, CA JAN 2021 – AUG 2022
Manufacturing Engineer
Responsibilities:
• Developed and approved quality system documentation such as operations procedures and work instructions.
• Worked with Manufacturing Engineers in developing process validation protocols, FMEAs, quality plans, manufacturing procedures, inspection plans, and specifications.
• Responsible for implementing and maintaining supplier qualification/ disqualification, supplier monitoring, product validation, and process validation.
• Utilised IBM Rational DOORS for managing and tracing requirements throughout the project lifecycle, ensuring all requirements were met.
• Responsible for first article inspection, incoming and in process inspections and lot release testing, including sampling strategies and test methods.
• Validations: Development of test methods, process validation (IQ/OQ/PQ).
• Risk Management: FMEA and fault tree analysis.
• Support and perform Quality Audits - Internal, External, FDA, BSI Regulatory Bodies.
• Ordering & Purchasing for Production, Quality Control and R&D teams; performed quarterly inventory for Production team, point of contact for vendor representatives.
• Collaborated with cross-functional teams to integrate PLC systems with SCADA and DCS, providing technical support and ensuring proper documentation of system upgrades and changes.
• Implemented data acquisition and logging solutions using Rockwell PLCs and FactoryTalk Historian. Collected and analyzed real-time data to monitor system performance, identify trends, and drive continuous improvement initiatives. Utilized data to enhance predictive maintenance strategies and optimise operational efficiency.
• Prepared detailed User Requirement Specifications (URS) for automation projects.
• Developed and tested products to meet IEC62336 EMC standards, ensuring electromagnetic compatibility in diverse environments.
• Production impact assessment: Analyze and rationalize CAPAs, Nonconformance (NCs) & Observations, Failure Investigations and root cause analysis.
• Evaluated product and process performance such as, pareto charts, statistical process controls, and process maps.
• Communicate with customers and suppliers on issues related to product quality and performance.
• implement quality and continuous improvement strategies within the quality and manufacturing system.
• Formulated and implemented strategies to achieve EMC compliance, including design modifications and shielding techniques.
• Prepared comprehensive EMC test reports, outlining procedures, results, and compliance status as per IEC62336 standards.
• Created and maintained supporting documentation, SOPs, and work instructions compliant with GMP for medical devices. Skilled in writing and executing process validations, leading practical problem-solving projects, and ensuring compliance with Good Manufacturing Practices (GMP). Developed process FMEAs, control plans, and conducted line performance monitoring to remediate systemic issues.
Resilience Ohio NOV 2018 – DEC 2020
Sr.CQV Engineer Responsibilities:
• Participated in Design History File (DHF) Remediation as a Quality Engineer and Verified the quality and completeness of DHF documents including DFMEAs and research reports.
• Comprehensive understanding of Design History File (DI-IF) and associated remediation activities Ordering & Purchasing for Production, Quality Control and R&D teams; performed quarterly inventory for Production team, point of contact for vendor representatives.
• Responsible for all aspects of quality assurance activities for manufacturing and engineering on multiple programs.
• Participated in the development and maintenance of PFMECA, PQP, QRD, Corrective action / preventive action, first articles, inspection plans, check lists, and SOPS.
• Develop technical studies, Risk analysis, process mapping, DOE’s, Gap analysis, statistical rationales, discrepancy reports, among other documentation.
• Authored DI-IF requirement documents, verification & validation plans/reports, functional verification protocols and reports, DFMEAs, and other risk documentation for multiple design change projects. develop a multi-level DHF architecture to help ensure compliance with procedures and regulations to sustain product DHFs.
• Traced verification and validation data to design inputs within the DI-IF architecture.
• Responsible for all aspects of Quality Assurance activities for manufacturing and engineering on multiple programs.
• Performed Risk Analysis and FMEA and initiate SPC for product and process success.
• Assists in investigations associated with Out-of-specification (OOS) and Non-conforming material reports (NCMR), Deviations, CAPA, Supplier Corrective Action Reports (SCARs).
• Participated in the development and maintenance of PFMECA, PQP, QRD, Corrective Action / Preventive Action, First Articles, inspection plans, checklists, and SOPs.
• Develop Technical Studies, Risk Analysis, Process Mapping, DOE's, Gap Analysis, Statistical Rationales, Discrepancy Reports, among other documentation.
• Responsible for Customer Complaint Investigations, CAPA projects, Cost Reduction and Continuous Improvement projects, Quality Systems Excellence among other projects.
• Experience conducting audits, risk analysis, risk assessments, PFMEA, DFMEA to corporate quality systems.
Endologix - Milpitas, CA JUNE 2016 - OCT 2018
CQV Engineer
Responsibilities:
• Developed and executed IQ, OQ, PQ documents, UAT, FAT, SOP’s and Engineering Change Requests.
• Prepared IQ, OQ, PQ protocols for new and modified manufacturing equipment, processes, systems, facilities and utilities.
• Created and executed commissioning and qualification protocols, test plans for facilities, utilities and equipment using a risk-based approach.
• Implemented and coordinated commissioning and qualification of manufacturing equipment and computer systems for use in regulated and non-regulated operations.
• Prepared protocols and reports related to equipment, system, utility qualification (IQ/OQ/PQ), calibrations, engineering, process, packaging, and cleaning validations.
• Supported the investigation of deviations, troubleshoot problems, and determines solutions.
• Provided equipment, system and facility commissioning and qualification guidance and strategy execution during project planning and development phases.
• Planned, executed, and documented internal testing of new equipment.
• Reviewed Risk Assessment Documentation to check the areas with deficiency, reviewed Corrective and Preventive Action (CAPA), STAT testing and drafted Remediation Plans for the project management approvals after the GAP Analysis.
• Developed detailed Project Plan, reviewed User Requirement Specifications (URS) and Functional Requirements Specifications (FRS).
• Authored and reviewed cleaning validation protocols and reports. Developed Cleaning Validation Matrix with worst case cleaning techniques.
• Authored commissioning and qualification of CSV documents through system life cycle including deliverables such as user requirements, functional, design specifications; qualification protocols, reporting, and support documentation.
• Reviewed laboratory requirements and defined the procedures for instrument and data management, data integrity.
• Implemented 21 CFR Part 11 for new and existing testing computerized laboratory instruments, performed gap assessments and defined resolutions in compliance with cGMP requirements.
• Supported installation activities when needed to ensure proper systems start up and recommended changes to improve system design.
• Regularly interacted with external development partners and equipment suppliers, Quality, and IT group.
• Developed risk assessment, system impact assessments and validation plans.
• Investigated deviations and wrote investigation report.
• Reviewed, analysed and interpreted system performance data for completed qualification and prepared final package to summarize data tracked and monitored the reviews and approval of validation deliverables and participated in meetings with the project team and Client as required. BHARAT BIOTECH Hyderabad, India NOV 2014-FEB 2016 Validation Engineer Responsibilities:
• Support manufacturing facility transfer and product transfer activities to offshore facilities.
• Supplier approvals and the continual evaluation of supplier performance including supplier audits.
• Involved in Engineering Trials like temporary deviations in sending parts to customers before PPAP.
• Communicate with customers and suppliers on issues related to product quality and performance.
• Implement quality and continuous improvement strategies within the quality and manufacturing system.
• Troubleshoot equipment and process issues. Summarize and conclude from test results leading to effective technical resolution of process problems.
• Responsible for customer complaint investigations, CAPA projects, cost reduction and continuous improvement projects, and quality systems excellence among other projects.
• Experience conducting audits, quality systems investigations, CAPA projects, Cost reduction and continuous improvement projects, quality systems excellence among other projects. Disposition non-conforming material requiring advanced process/technical knowledge.
• Work directly with suppliers to prevent or correct discrepant material Perform Detailed Root Cause Investigation of failed product or processes using various quality tools (5 Whys, 6 M, Ishikawa Diagram, Pareto Charts). Implement corrective and preventative actions.
• Product Impact Assessments: Analyze and rationalize CAPAs, Non-conformance (NCs) & Observations, Failure Investigations and root cause analysis.
• Created Change Control and DHF Remediation processes using Lean Methodologies (Kaizens, A3s, and Standard Work).
EDUCATION:
Bachelor's in mechanical engineering June 2010 – May 2014
Contact this candidate