Hardik Kumar Balvantbhai Patel

Oconto, WI

ad1y3o@r.postjobfree.com

848-***-****

SUMMARY:

• 8 Years of experience as Packaging Engineer in packaging environment with expertise in (I, II & III) medical devices industries.

• Experienced Packaging Engineer with expertise in Root Cause Analysis, Process Validation, Packaging Validation, and Continuous Quality improvement.

• Experience in packaging and labeling projects. Packaging innovations, packaging planning and validation, packaging and labeling improvement projects, development and design of test methods, validation and protocols for packaging and labeling development projects.

• Strong analytical skills and strategic product development, verification/validation activities with extensive comprehension of cGMP for Class I, II & III medical devices.

• Experienced in performing remediation of existing sterile packaging for Medical Device implants to comply with ISO11607-1 and ISO11607-2 (Packaging for Terminally Sterilized Medical Devices).

• Expertise in statistical analysis methods i.e. six-sigma, Principle component analysis, Root Cause Analysis tools: DMAIC, 5 Whys, etc.

• Hands on experience in creating the Design History Files (DHF) and updating them as per the changes made in the due course of design of the product line also has working knowledge of GD&T and experience in Process Validation and Test Method Validation.

• Experience using continuous improvement tools, such as FMEA, Root Cause Analysis, SPC analysis, and process mapping also experience using Statistical Process Control and process analytics.

• Expert in test method/setup optimization, test fixture optimization, test data and yield Hands on experience in DFMEA and PFMEA Analysis Experience in Analysis and real-time investigation of yield and test issues for both in house and outsourced assemblies.

• Extensive Device specific engineering and development, and manufacturing for Classes II & III, ISO 9001, ISO 13485 (Quality Management Systems), ISO 14971 (Risk Management, Devices), 21 CFR 820 (FDA Devices, US), working familiarity with European Standards - Devices.

• Accomplished professional with a robust background in process manufacturing and conversion of flexible packaging, specializing in blown film and metallization techniques. Proven expertise in optimizing production processes to enhance efficiency and product quality.

• Experience in SolidWorks, Pro-E; 2D and 3D modeling experience, also experienced in simulation software ANSYS also knowledge of Microsoft Office Suite as well as statistical software packages (Minitab).

• Strong foundation knowledge of statistics, regression analysis, and design of experiments also knowledge of CAPA systems.

• Experience with medical device compliance requirements based on FDA Quality Systems Regulations.

• Subject matter expertise in packaging engineering or device/combination product assemble experience working in GMP (Good Manufacturing Practices) and GDP (Good Document Practices).

• Proficient in the process manufacturing of flexible packaging.

• Specialized knowledge in blown film and metallization techniques.

• In-depth knowledge and hands-on experience in flexographic printing, extrusion coating, adhesive laminating, and slitting/winding operations.

• Specialized training in flexographic printing and converting processes, reinforcing expertise in the field.

• Hands on experience in Design controls and DHFs also experience with reviewing Device Master Records (DMR). EDUCATION:

• Master in Geospatial Intelligence, University of the Potomac May2020-May 2021

• Master’s in cyber security, University of the Potomac January 2019 –April 2020

• Master of Information system Management, American College of Commerce and Technology 2016

• Master of Science in Organic Chemistry, Sir P.T Science College, Gujarat, India 2014

• Bachelor of Science in Chemistry, The H.N.S.B Ltd Science College Gujarat, India 2012 WORK EXPERIENCE:

Getinge Wayne NJ(Remote) March 2022- Current

Engineer II Quality

• Create new text layouts for multilingual print media such as IFUs, labels, patient record labels and inserts, etc. - 20%

• Update Package Engineering SOP’s to comply with FDA and EUMDR regulations. 20%

• Coordinate development and approval of graphics, labeling and illustrations for cartons, labels, IFUs,etc - 40%

• Enter data into the in-house Labeling System and release labeling specifications and parts on Windchill. – 20%

• Managed and operated flexographic printing presses, ensuring high-quality printing on flexible packaging materials.

• Implemented color management processes, resulting in improved print consistency and color accuracy.

• In-depth knowledge and hands-on experience in flexographic printing, extrusion coating, adhesive laminating, and slitting/winding operations.

• Execute assigned Post-Market Surveillance activities including Complaint Assessment, Reportability Determination, and Final Complaint Review primarily for low severity complaints. Flow to Work to assist other team members as needed.

• Responsible for providing Post-Market Surveillance support for assigned mills/products. Responsible for completing Low Level Complaint Investigation records, as needed.

• Applied specialized knowledge in metallization techniques, contributing to the development of high-quality packaging with superior barrier performance.

• Executes continuous improvement plans and activities for established processes as assigned.

• This position will assist in ensuring compliance to FDA, ISO, and other applicable regulations and standard.

• It provides technical support for multiple projects primarily within the Cardiac Assist business units, however some cross-over into the Cardiac Surgery/Vascular Intervention business unit may be required as needed.

• Manage applicable CAPAs and perform CAPA effectiveness checks as required. (20%)

• Performs external standard assessments to standards, regulations, guidance documents assigned to Quality Compliance

• Conducts thorough review of the changes and meets with process owners, as needed, to identify the required actions to be taken to address the changes and potential gaps.

• Works with Quality Compliance process owners and processes change notices in Windchill.

• Maintains relationships with Consumer Services, including reporting of and troubleshooting errors, and coordinating complaint handling activities and improvements.

• Builds and maintains capability for compliance with QMS, ISO, and FDA GMP's to support objectives.

• Establish procedures for validating equipment, processes, and Quality Control and Production methods. Becton Dickinson, Warwick, RI (Remote) July 2021-February 2022 Quality Engineer II

• Managed packaging project maintained and scheduled projects and its resources.

• Led the manufacturing and conversion processes for flexible packaging, demonstrating specialized proficiency in blown film and metallization.

• Implemented strategic improvements in blown film extrusion, resulting in increased production efficiency by X%.

• Managed the metallization process, ensuring the consistent application of metal layers for enhanced barrier properties.

• 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.

• Knowledgeable of quality systems and the new product development process

• Thorough knowledge of manufacturing processes and the ability to design within reasonable limits of these processes.

• Proven knowledge of Engineering Principles and Practices, specifically knowledge of applicable codes and standards

• Excellent knowledge regarding quality expectations, planning and development of packaging and material flow system.

• Participate in Risk-Based evaluations, utilize Risk Assessment Methods/tools, and provide technical input during FMEA processes.

• Assure Compliance with FDA and EU Regulation.

• Evaluate, document, and develop investigations attributed to qualifications failures.

• Author Summary Reports, events, and applicable protocol amendments

• Execute and/or provide support during protocol executions.

• Spearheaded extrusion coating operations, applying a deep understanding of coating technologies to enhance product performance.

• Optimized coating parameters, resulting in a X% increase in coating efficiency and reduction in material waste.

• ed adhesive laminating processes, collaborating with cross-functional teams to develop laminated structures with specific performance attributes.

• Implemented adhesive selection criteria, contributing to the development of laminates with superior bonding strength.

• Managed slitting and winding operations, ensuring precision and accuracy in the conversion of large rolls into smaller, customer- specified dimensions.

• Implemented efficiency improvements in slitting processes, reducing downtime by Y% through streamlined workflows.

• Assure all the qualification items are tracked and successfully completed.

• Perform GAP analysis and provide recommendations for existing qualifications.

• Validation/Qualification activities will cover - software, automated systems, laboratory instruments, production equipment, packaging systems, and facility utilities (HVAC, Water, etc.) Evaluate the operation of Manufacturing and Quality activities in relation to compliance to Quality Standards and Regulations and recommend where corrections or improvements are indicated. Medtronic, Denver, CO (Remote) July 19 – July 2021 Packaging Engineer

• Responsible for medical device packaging development for new product development, sterilization, aging, testing and evaluation as per ISO11607.

• Lead design, test and implement packaging designs that are part of the product development process.

• Supported change control process by reviewing, creating or updating packaging specifications and documentation.

• Managed complete packaging development process, including packaging designs, prototype development, performance testing.

• Responsible for effectively and efficiently leading packaging and labeling design change projects from initiation to completion.

• Responsible for troubleshooting the new and existing problems involving designs, materials, and process by providing creative, time and cost-effective solutions.

• Ensured packaging components were verified in testing in accordance with ISO11607, ASTM D4169, and internal procedures.

• Developed and executed protocols for package design, packaging processes validation and package shelf life testing.

• Worked with packaging technical operations, New Product/Packaging Development, Quality Teams and Materials Management to Develop Effective strategies that drive Business Performance Excellence with in the Packaging Commodity and Supply chain.

• Analyzed engineering drawings and specifications of product to determine physical characteristics of item, special handling, environmental and safety requirements, and types of materials required for packaging.

• Worked on various projects involving packaging validations which is Packaging qualification study & Stability Studies (Accelerated

& Ambient) for the new packaging materials.

• Planned, coordinated and executed GMP System Audits for packaging and labeling processes. Performed Design of Experiments

(DOE) to optimize settings of Label Printers.

• Formulated process drawings, process flow charts that contributed for new product designs and modifications also developed and maintained Global and Regional CAPA databases.

• Identified and implemented cost saving initiatives related to packaging material, efficiency, transportation and storage.

• Material specifications were developed for packages based on the testing results.

• Interacted with R&D, manufacturing, marketing, graphic design, regulatory, purchasing planning teams as part of the projects.

• Provided guidance and assured compliance to packaging quality and Regulatory standards thru frequent interaction with project teams, manufacturing facilities and contract manufactures.

• Involved in various remediation projects by performing packaging gap analysis to ensure and meet EUMDR regulations.

• Made sure that all the regulations like EUMDR, ISTA – 1A, ISTA – 2A, ASTM (Simulated Distributed testing), ISO 11607 – 1 & 11607

– 2 are met.

Boston Scientific, Maple Grove, MN Apr 2017 – Apr 2019 Packaging Engineer

• Responsible for the execution of packaging validations for new, or existing products, following ISO11607 regulations.

• Assisted in procedure development and maintenance, quality validation after mold repair, including capability studies, Gauge R&R, first article reports, etc also operated various inspection instruments and handheld gauges.

• Worked on Sterilization methods / testing, clinical processing, packaging design (ISO 11607) / shelf-life studies.

• Responsible for leading the development of robust packaging testing solutions that comply with ISO 11607 and ASTM standards.

• Ability to oversee the documentation of nonconformities, trending of company processes, as well as documented nonconformance’s into the Corrective Action/Preventative Action (CAPA) program.

• Wrote engineering studies and reports to ensure current packaging line can successfully add new information on product label.

• Provided engineering support with regards to new FDA UDI required label designs and systems to read and process these labels.

• Responsible for conducting and closing investigations, determining root cause, and implementing/closing CAPAs.

• Assisted packaging engineering department in packaging laboratory testing of new packaging concepts and validate new packaging designs through extensive testing protocols.

• Reviewed validation (IQ/OQ/PQ) and provided technical input to ensure validation reports were qualified to company and regulatory requirement.

• Responsible for developing packaging components for new syringe products from design phase through to prototype testing and final model manufacture. Work steps in this process included conceptual design, design freeze process and verification of design.

• Involved in specifications and selection of foil (heat seal) packaging and support equipment (leak testing) for the site to meet customer needs and critical process parameters.

• Coordinates the implementation of unique device identification (UDI) for labeling and packaging equipment’s.

• Responsible for trouble shooting and act as subject matter resource on packaging line operations, changeover issues and internal handling of packaging materials.

• Developed Packaging Process Validation protocols and SOPs. Assisted in SOPs, CAPA, OOS Investigation, root cause analysis and was responsible for product design reviews and m20old transfer process.

• Drove supplier development by assisting them in developing problem-solving control tools such as: process mapping, FMEAs, mistake proofing, Process Capability/Cpk etc.

• Assisted product development in quality control procedures, development of test protocols for new equipment procurements

(IQ/OQ/PQ) and introducing best practices to manufacturing.

• Established the manufacturing procedures for the monitoring, operation, and control of the devices and equipment. Inva Tech Pharmaceutical East Brunswick, NJ May 2015 – Feb 2017 Quality Assurance & Regulatory Affairs

• Data entry and maintenance within the Pharma Raw Materials Program.

• Preparation of analytical documents for FDA submissions.

• Data entry and maintenance within the pharma sample program. Data audit generated by the quality control laboratory.

• Maintenance of Track Pro Calibration Software for equipment and instruments.

• Preparation of Trend Analysis reports for stability chambers, Temperature/Humidity and Water Qualification.

• Preparation of annual review documents and evaluation of field and current document.

• Author, review, and/or approve Validation Lifecycle documentation, including Validation Plans, User Requirements Specifications

(URS), Functional Specifications (FS), Design Specifications (DS), SOPs, Change Controls, deviation reports, Summary Reports, risk assessments, TM (Traceability Matrix), commissioning, qualification, and IQ/OQ/PQ protocols, equipment, and process Failure.

• Mode and Effects Analysis (FMEA), compliance documentation according to cGxP guidance for audits, process performance, procurement, and compliance evaluations.

• Mode and Effects Analysis (FMEA), compliance documentation according to cGxP guidance for audits, process performance, procurement, and compliance evaluations.

• Performs continuous process verification (CPV) and periodic data analysis.

• Lead the validation projects, ensuring successful, timely completion.

• Plan and oversee the cGMP manufacturing development and implementation of all validation processes and equipment through change management and change control system for equipment, utilities, facilities, and processes.

• Assess change controls for the impact of any change to the process, equipment, or procedures.

• Plan, Write, review, and recommends corrective actions to management and documentation results.

• Plan and initiate risk assessments, aiming to maintain compliance with systems, processes, materials, equipment, utilities, and facilities till completion.

• Ensure, apply, and address compliance to validation principles and regulations for all Validation activities and tasks.

• Collaborates with Employees Training on validation procedures and policies for cross-functional teams.

• Review of raw data relevant to method validation and cleaning validation studies.

• Review of raw data relevant to product development and process validation.

• Review, archiving and preparation of stability data and daily calibration. Compilation of method validation studies.

• Review and design final report for FDA submissions.

• Review of raw data relevant to laboratory deviations, out of specification investigations and complaints.

• Understand and follows all GMP, SOPs and written test procedure. Follow SOPs in reference requirement documentation.

• Reviews and design following documents: Protocols, SOPs, Instrument qualification, test procedure, reports, analysis of data.

• Review of raw materials, stability, In Process, Blend, Finished Product, Process Validation samples, In accordance with company test methods.

• Preparation of Trend Analysis reports for stability chambers, Temperature /Humidity, and water system qualification

• Preparation of supplements to approved ANDAs and other issues pertaining to any applications.

• Preparation of supplements to approved ANDAs and other regulatory requirements within the company.

• Preparation of annual review documents and evaluation of field and current document relating to the ANDA.

• Preparation of analytical documents for regulatory submissions.

• Assistance in Quality Assurance and regulatory Affairs duties.

• To assist in preparation of annual review documents and evaluation of field and current documents relating to the ANDA. Seimens Healthcare, INDIA Feb 2013 – Oct 2014

Packaging Engineer

• Lead the advancement, usage, support and constant change of manufacturing procedures, tools, apparatuses and investigation to build proficiency, adaptability, creation, quality and reliability of existing items.

• Worked with Engineering to establish and maintain part and assembly specifications and created test methods and fixtures for destructive strength tests and used Lean Six Sigma tools to improve process variability and efficiency for packaging/support equipment.

• Developed package specifications, work instructions and Bill of Materials (BOM) documentation also prepared and performed IPs, Process Confirmation/ Validation, DOE’s protocols and final reports.

• Prepared validation protocol documents like IQ’s, OQ’s and PQ’s for all aspects of validation of packaging equipment in accordance with FDA regulations andvalidated packaging equipment and packaging manufacturing processes also performed root cause analysis for product/process failures.

• Performed system validation using GAMP guidelines to conform compliance to FDA and 21 CFR Part 11 requirements.

• Conducted review of manufacturing, quality control, and packaging specifications as part of complaint investigation to ensure products were manufactured according to specifications.

• Reviewed, identified and remediated legacy CAPAs for proper content (containment, problem investigation, risk assessment, GDP, root cause, action plans, etc) and determined root causes and appropriate CAPA for analyzer manufacturing exceptions.

• Involved in supporting manufacturing in sourcing, procurement and validation of key pieces of packaging equipment; qualifications (IQ, OQ, PQ), design of experiments (DOE) and validations.

• Contributed to process improvement- characterization projects, either Packaging or Manufacturing areas, and ensure quality aspects of the product also reviewed drawings for accuracy, material selection, proper machining techniques, finishes, and hardness Written and executed Change Verification Protocols for the medical device

• Became familiar with engineering drawing conventions and a wide array of technical specifications also responsible for ensuring the compliance of GMP/GLP and FDA regulations.

• Developed and approved new supplier’s quality and production systems to ensure that the plant purchased parts meet the product specifications.

• Involved in reviewing Corrective Action and Preventive Action (CAPA) and drafting Remediation plans for the project for the project management approval after GAP analysis.

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