Galina — Engineer

11/2011 - current: Consulting engineering services for various clients. Process and product improvement activities; gap analysis and recommendations for efficient product manufacturing process; creating proposals for manufacturing process improvement with the intention to reduce scrap and increase safety; creating Factory Acceptance Testing protocols; maintenance and security manuals; work with high speed processes, materials, thermal processing; and packaging, proposing mechanical systems design options; solutions for increased systems efficiency in improved work place organization; work with controls, maintenance, production management and teams; troubleshooting; assessment; and presentations. Consulting activities contributing to design and development of custom pressurized systems that utilize variety of HVAC equipment, piping, instrumentation and accessories, in variety of environments, with range of temperatures, humidity and pressure conditions. Offering new conceptual approach to systems design and validation; creating new calibration procedures via research and cooperation with unique design solutions teams. Interface with suppliers and offering new technological approaches. Optimizing process layout, selecting best equipment and components, manpower estimates. Documentation, meetings, testing, calculations, and programming

2006 - 2007: Boston Scientific (NY & IN), medical devices, Senior Validation Engineer: Oncology & urology; development, execution and support of test method validations, fault induction, validation remediation. Resolution of customer complaints / non-conformances to meet FDA, US & EN guidelines. Mentoring & training operators, hands-on in manufacturing and tech lab. GAP analysis, internal audits, risk assessment. Measurement system re-evaluation & re-calibration for testing. Developing and conducting Attribute and Variable, Destructive and Non-Destructive testing. Creating Technical Reports, Test procedures, Validation protocols and Reports. Writing new test methods and redlining existing graphical operating instructions. Statistical analysis with Minitab, including process capability, R&R; DOE; building charts and histograms. Created and executing computer programs for leak tests (SPRINT) and tensile tests (LF Plus Chatillon) equipment, with both numerical and graphical output. Participating in testing equipment and aids design and re-design activities, offering solutions, ordering mandrels and parts for tests. Offered improvements to testing process. Arranged microbiology testing of test aid devices. Communicated with suppliers, engineering; tech lab and production; scientists, R&D, CAPA groups, Quality dept. Projects included Malecot Catheter Bond Tensile Studies; Temp Tip; RO Marker; VSC catheters; Guidewire CAPA - investigation of non-conformances and proposition of solutions. Utilized PDM and SAP databases; Device Master Records. Updated DFMEA, PFMEA, SOPs, Specifications, Quality Plans, MVP; and MVR documentation. Leak test for closed systems; pull test to verify UV bond integrity of the hybrid dual check valve assembly

4/2011 - 10/2011: Engineer, medical devices, Frank Crum. Product development for Therapeutic Support Systems. Product design, prototyping, specifications development, verification of design and product functionality. Verification and validation of equipment and software, including hospital beds. Conducted debug, tested how different programming versions affected beds' functionality; ensured computer systems validation and design / performance optimization with different software versions. Assessed testability of engineering requirements and recommended needed tests. Made consistent recommendations to Requirements Traceability Matrix - design process map, which included customer needs from marketing perspective, engineering requirements (ERs) and specifications, verification and validation testing to meet ERs and specifications. Project management: scheduling, discussions. Conducting verification tests locally and in remote testing facilities. Conducted variety of tests and coordinated their execution. Made recommendations to change, add or remove engineering requirements. Cooperated and communicated with electrical, electronics, biomedical, mechanical and R&D engineers, quality department, manufacturing, and local and remote test labs

4/2010 - 11/2010: Plant Engineer for Allison Transmission. Project management, HVAC, new equipment and facilities, renovations, negotiations, bidding, equipment selection, and meetings. Projects included: Roof replacement and building re-facing projects; replacement of Cooling Towers, Chillers, Air Compressors, Air Handling Units, ductwork and accessories; support of Security department. Worked with HVAC, mechanical and electrical systems; utilities, indoor and outdoor facilities; conducted their assessment, design, repairs, improvements and new construction. Conducted assessment of products and subcontractors services; worked with specifications, submittals, and bid packages. Conducted and managed air balancing and heat loads calculations for production floor, labs, testing areas, computer rooms, mezzanines and offices. Collaborated with Structural Engineering Firms, Engineering and Architectural Firms, and Pavement contractors. Supervised asphalt repairs, concrete replacement and building structures for gravel and sand storage; gathered bids and conducted pre-bid meeting for High Speed Test Track Seal Coat. Provided HVAC systems design and optimization

3/2010 - 7/2010: Consulting Engineer for Procure, medical devices. Development of quality system for medical devices company. Work with regulatory standards and guidelines to ensure proper practices for 510K submission and overall product design and development effort. Working on all stages of quality process, starting from Proposal and all the way through URS, FRS, Specifications / Requirements, DFMEA, Risk Analysis, through design, verification / validation and testing to product implementation. Created templates for major documentation; worked with product CAD drawings. Created presentations, participated in meetings and discussions. Work with products and documentation development, research and projected stages of addressing quality systems steps in reality

9/2008 - 12/2008: Project Engineer, compounding, Archimica. Process development for new finished pharmaceutical - Naproxcinod and intermediates. Creating and updating drawings, PFDs, & P&IDs. Sizing up & selection of pumps, vessels, accessories & heat exchangers. Redefining piping specifications. Creating of a Control Scheme for BDMN Extraction Columns. Working with customer and vendor documentation, including transmittals. Hands-on and field trips. Cooperation with management, regulatory, maintenance, pilot plant, manufacturing, chemical engineers, and quality personnel. Participating in design review meetings. Computer systems validation - suggestions of strategy, execution, deliverables clarification, support with standards and their interpretation, utilizing computer systems infrastructure & info on Allen Bradley / Rockwell PLC and GE Fix Intellution products. Defining URS / BOD outline & supporting it with standards. Made recommendations and suggested strategy to perform computer systems validation. Ensuring compliance with NFPA guidelines; GAMP-4 recommendations; 21 CFR Part 11, RCRA, ICH-Q71 - GMP Guidance for APIs

9/2007 - 2/2008: HVAC / mechanical engineer for DPT Labs. Work in Capital Engineering department for utilities / facilities improvement. Vendor assessment. Work with BOD, quotes, proposals and CARs. Scope of work and invoices negotiation. Projects scenarios analysis. Managed Alcohol lines & USP water system projects. Oversaw equipment installation, positioning, connections, accessorizing, & supply with utilities: water, electricity, compressed air, drain; ceiling & walls modifications; fire alarms. Water lines survey and capacity expansion. Suggested validation strategy for USP water system and participated in validation meetings; broad participation in validation activities, their planning and analysis, cooperation with validation department, ensuring quality compliance. Generated URS, Change Controls, Meeting Agendas, schedules; created Maintenance and Sanitization procedures. Alcohol System project: Developed process for N purge; secondary containment; arranged and led redundant lines removal with hot work & leak testing; supervised lines passivation. Identified issues in costeffective manner to convert those into proposals; helping eliminate redundancy in the facility, plan and conduct repair or replacement or existing systems; & expand utilities for manufacturing process. Identified problems to bring facilities to FDA, NFPA, OSHA, oil & gas industry, & building standards. Assessed & helped improve control systems. Selected oxygen monitors. Ensured compliance of pumps, filters, materials, oxygen monitors, and pressure & flow instrumentation with performance requirements

11/2006 - 1/2007: Test / Mechanical Engineer at DRS / Marlo Coil (military). Testing, debug and validation of HVAC system powered up by diesel engine and regulated with custom control system. Hands on activities. Test preparation. Building of electrical heating system to heat water in cold water tank with the intent of subsequent chilling from required hot temperature. Supplying power to heating system. Acquisition of parts. Selection of equipment and devices (including flow regulating devices) to improve system performance. Verification of engine / generator power output. Eliminating leaks and improving insulation. Hot Room Testing execution and monitoring of critical testing parameters. Testing of electrical systems. Monitoring temperature with thermocouples / data logger / PC. Creating charts. Evaluation of alternative fuels - JP8 / kerosene vs. diesel. Evaluation of alternative power sources - shore power and generators. Work with wiring diagrams and refrigeration system schematics. Comparison of purchase description / test requirements with the testing setup in order to ensure verification of robust system design and successful testing process. Participated in priming and painting exterior system parts. Equipment shipping. Writing of test procedures and test reports. System Manual Revision

2/2006 - 8/2008: Project Manager for Nuclear facility (Indiana University Cyclotron Facility). Managed safety project at the nuclear facility delivering proton beam for MPRI cancer treatment clinic. Coordinated validation and testing activities for Treatment Room 2 by a third party to ensure FDA compliance. Liaison between vendors, local departments and customers. Created Purchase Requests, procedures, work orders, NEC reports, Hazards & Requirements traceability matrix; test protocols and reports. Assured SELV compliance of power supplies and GFCI compliance of sensitive electrical systems, dealing with patient treatment. Helped to reduce cost for vendors' services and electrical and mechanical devices / equipment acquisition. Input to projects' schedules. Participated in setup & reporting for EMC / EMI testing. Created mechanical test setup and provided input for updating drawings. Revised wiring diagrams. Monitored equipment upgrade and repair work. Worked with Hazard Analysis, recommended updates to Proton Therapy System UM and FMEA. Assured compliance to UL, IEC, EN & ISO standards by arranging NEC inspections with follow-up systems modifications. Calculated wattage of AC and DC power supply systems. Worked with UP200 welding high speed robot; coordinated its testing / validation & certified for use in cancer treatment facility compliant with ambulatory requirements. Worked with data sheets & certificates of compliance. Used Maintenance database, Orcad and Adept programs, Powerway, Sharepoint, MS Project Server. Worked with Emergency Stop, Dose Delivery, Beam Delivery, and Patient Positioning systems. Interfaced with customers medical personnel; physicists, outside vendors; mechanical, electrical and electronics engineering and maintenance crews

5/2005 - 9/2005: Baxter, Senior Validation Engineer. Process validation and gap analysis. Evaluating performance of new manufacturing lines for Transfusion Therapies and supporting Medical Delivery division. Assessed test methods and manufacturing instructions for consistency with product and process specifications on Amicus new manufacturing line. Generating Validation Plans and Protocols & their execution. Pre-validation assessment. Projects: Isolex fixture for PCB and other components testing of Isolex machine. Research on optimization of Alyx instrument CPLD chips programming with JTAG application on In Circuit Test station; Functional Test Station or in Mfg area. Participated in validating Alyx - a complex unit, run by software and used for separating blood products. Assessed and controlled ESD (Electro Static Discharge) and ground protection and compliance on the manufacturing floor. Modified assembly floor layout. Worked with low voltage and high voltage units and with voltage regulators. Worked on project assessment for moving Amicus New Manufacturing line into another building. Learned company business and FDA regulations, supported by local procedures. Received training on HomeChoice renal product and educated myself about renal care issues. Made recommendations about improving business practices and coordinated projects activities

1/2005 - 6/2005: Navistar, Senior Project / Validation Engineer. Body / Interiors group - coordinated activities between design, development, testing, validation and implementation to production of HVAC / Plumbing / Connections to Fuel Systems for Medium and Heavy-duty trucks for civil and military applications. Assessed vendors and suppliers, did comparative concept & performance analysis with cost considerations Analyzed energy sources; suggested improvements to vehicle systems design, including fuel and coolant systems; HVAC systems, interiors insulation; plumbing, connectors, instrumentation, tanks - each separately and in conjunction with all vehicle systems. Worked with Quality documentation and specifications, addressing compliance with safety, NFPA, ANSI and other guidelines and internal procedures. Communicated with regulatory, ergonomics depts, vendors and purchasing; design and test engineers; development and test labs; road test facilities mechanics; noise test personnel; shaker lab personnel; exhaust group personnel, cold room personnel; FEA Analysis and Vehicle Dynamics groups. Worked closely with project leaders and with HVAC and Test group managers. Participated in testing activities and composed tracking, testing and reporting documentation, including Project Timelines, DVP&R (Design Validation Plan & Report), DFMEA (including boundary diagrams & interface matrices). Projects: Coolant Heater for no-idle applications; AC for no-idle; Defrost solutions; requirements research for Electrical Dash AC system

2/2002 - 2/2003: Eli Lilly, Senior Validation Engineer. Development & execution of IQ, OQ,& PQ validation protocols; commissioning; supporting Quality Assurance. Created Tasks Lists, SOPs and Maintenance Procedures, Test & Validation Plans, Protocols and Reports, Change Controls, Requirements Documents, Design Documents, Requirements & specifications, and traceability documentation. Utilized mechanical, piping, electrical, architectural, and structural drawings and P&ID diagrams, corrected blueprints. Managed projects and project teams. Worked with HVAC, Cooling Towers, Heat Tracing System, Fire Protection systems, Alarms, Electrical/Controls, Compressors, Pumps, Tanks, Filters, including HEPA filters, Sensors, Valves, Piping, other instrumentation, including Measuring / Controlling devices. Projects in dry and Parenteral areas included: Assessment for New Automation / Controls Upgrade effort; Chill Room, Control Temperature Room, Chilled Water Room, Clean Air Projector for Freeze Dryer, Steam Sterilize-in-Place system for use by the Parenteral Products Manufacturing Department, QC (Animal) Lab relocation. Wrote and executed Change Controls, including: Steam and Chilled water; Building Footer Extension; Electrical Tie-ins; All Utilities; UMS system; Punch-through; Modifications and Access Panel. Supported shutdown activities; calculated and compared parameters in equipment and utilities' systems. Did troubleshooting and testing and identified outstanding issues and created plans for resolving them. Sketched conceptual approach and strategy for new projects

11/1999 - 6/2000: Sagian/Beckman Coulter, Test / Development Engineer. Debug, testing, and development of Biomek-FX machines/instruments for biomedical drug discovery research. Design, validation and verification of software, hardware, firmware and electrical systems of biomedical robots. Wrote and executed test scripts. Wrote new test plans / scripts and edited existing ones. Conducted Test Method Validations. Hands-on, including machines and components assembly, disassembly and leveling. Used unique programming language similar to Visual Basic. Conducted data analysis

3/1999 - 11/1999: Roche Diagnostics, Process Validation Engineer. Project Management, process improvement and validation, working with capital equipment for manufacturing test strips with reagent. Test strips measure blood glucose level in diabetes patients. Ensured FDA compliance. Oversaw and conducted equipment & systems custom design, building, debug, validation, implementation to production and start-up of upgrades. Managed equipment design customization; debug & troubleshooting; vendor acceptance testing, shipment, installation, shipment, & validation in Indiana and Puerto Rico. Activities included hands on, R&D, dealing with cost issues & budgeting work with controls / PLC. Advised on resolution of equipment performance issues. Worked with temperature-sensitive raw material. Few tests examples: Monitoring tension and input voltage using Load Cell, Load Cell Power Supply and Strip Chart Recorder. Managed projects, coordinated activities between machine builders, customers, and vendors. Conducted meetings. Ordered spare parts and materials; wrote FMEAs, Control Plans, Equipment Operating and Maintenance Procedures, Lock-out / Tag-out Procedures, and validation protocols. Projects: "Sensor Punch SP-09", "Sensor Punch SP-10", "Labeling Machine LM-08", "Palladium Quick Change Over station for Sealing Machine SM-07

11/1997 - 2/1999: Delphi-E / General Motors, Process/Tool Engineer. R&D for generators manufacturing. Equipment and processes selection, testing, debugging, design, validation, and implementation to production. Business travel. Troubleshooting on motherboard malfunctions in rotor deburring project, saving money for the company. FANUC and Allen Bradley control systems. Documented electrical changes on prints. Operated and programmed custom balancer / vertical drill equipment system with unique software and sensor device for measuring rotors and removing extra material for balancing purposes; reprogrammed balancer for different generator models, including Chevrolet, Pontiac, Buick, Cadillac. Tested balancer performance; trained personnel and fulfilled customer orders. Analyzed process parameters to come up with the desired results. Worked with electrical, optical and mechanical instrumentation. Conducted R&R - Gage repeatability studies and gage isoplotting; ran CMM machine for stators measurement; designed stators and rotor handling fixtures. Utilized GD&T theory for practical purposes of handling and working with stators. Conducted electrical testing of bondable wire for stators. Programmed Sipro rotor coil winding machine parameters utilizing unique control software created by Sipro - Italian company. Created unique program for rotors deburring and did IQ, OQ and PQ studies for validating custom lathe ran of FANUC control system. Creating Equipment Operating Procedures, PFMEAs, Process Flow Diagrams, Control Plans, Process Routings, and running error proofing. Continuous improvement in Manufacturing Systems Design, Product Development, Electronics, and Statistical Process Control. Working on the following projects: "BTI Balancer", "SIPRO winder", "Development of Stator Re-rounding process", "Bondable Wire for Stators", "GT27 Lathe for rotor deburring", and assisting team members in their assignments. Received extensive process, manufacturing, and engineering training inside GM/Delphi plant, including SPC, Lean Manufacturing, Toyota Production Systems, Value Stream Mapping, Process Flow & Optimization