SUMMARY:

• Solutions - oriented Field Service Engineer with extensive applications experience and proven track record of effective installation, validation, service, applications, sales, troubleshooting and repair.
• Broad knowledge and success in managing the installation, testing, and servicing of technical and diagnostic equipment and software for immunodiagnostic, pharmaceutical and nutraceutical industries.
• Solid customer service,in-house field service and training abilities, offering dynamic technology-driven presentations to large and small audiences of varied technical expertise. Conduct training seminars and on-site custom tailored training solutions.
• Provide feedback to in-house engineering and quality control on new product development and product improvement programs.

TECHNICAL SKILLS:

Operating Systems: UNIX, Macintosh, Linux, Win 10, 8.1, 8, 7, Vista, XP/2000/NT/98/95/3.11, CE, DOS

Software: SAS, SAP, MS Office 2003 Professional (Word, Excel, PowerPoint, Access, Outlook), Visio 2002, XML, Web authoring, Crystal Reports, Lotus Notes, Flash paper, Adobe, Nautilus LIMS, Photoshop, PE Nelson, Empower, Matlab, SharePoint, Boxnet, Spotfire.

Hardware: LIMS, HVAC, Packaging, Blister Seal, Hardness Testing, Machine vision, Granulators, LAN, WAN, Routers, Wireless Interfaces, Vacuum, Optics, Pressure Pumps, LIS, Electromechanical Instrumentation (Vendor Specific) Boards, Diagnostic tools, Multimeter, Optics, Lasers, Oscilloscope.

PROFESSIONAL EXPERIENCE:

Confidential

Field Service Manager

Responsibilities:

• Field Service Analytical Equipment, GCMS, GC, LC, LCMS, Robotics
• Maintain, service, PM, PQ, IQ, OQ equipment, validation role
• Provide user training, support, technical knowledge
• Removal of equipment, set up and relocation of equipment

Confidential, Detroit, MI

IT Engineer - Validation LIMS Manager

• Install new computer equipment and configure.
• Proposed new work flow process changes, perform testing and execute new protocol in LIMS.
• Performed weekly status reviews and training events. Successful at implementing new process while FDA auditors overlooked newly implemented process. Author new procedure with sign offs and initiates procedures.
• Work on FDA part 21, 210, 21 expertises in IT pharmaceutical SOP’s, internal batch recording systems and manufacturing audit records.
• LIMS and instrument interfacing ability, with strong knowledge and working history of chromatographic and data handling software integration.

Confidential,Tarrytown,NY

Customer Service Manager

• Work as an Confidential performing, customer service, maintenance, repairs, and service on sample robotics, GCMS, GC Detectors, LCMS, MS, and general instrumentation.
• Remote assignment involve specialty authoring equipment and cleaning validation.

Confidential,Cambridge,MA

Field Service Engineer

• Provide on-site pharmaceutical, life science, and medical validation of instrumentation.
• Author custom validation procedures in accordance to CFR 21.
• Custom tailor facility compliance programs to suit laboratory requirements.
• Performed asset management duties and facilitate operations with company personnel.
• Provide Field validation of UV/Vis spectrometers LC, FTIR, dissolution, HPLC multidetection, GC multidetection, GCMS. LCMS, and other process equipment and reagents..
• Performed validation work on customer process equipment including Nautilus LIMS, packaging, sealing equipment, and specialized Minitab process.
• Worked with solid dose process, laboratory equipment and cleaning validation protocol. Initialize SOP’s and specialized factory in-line process.
• Author new process procedures, conduct weekly status update, and finalize new process changes with management approval.

Confidential, Long Island,NY

Customer Service Engineer

• Worked as an Confidential performing, customer service, maintenance, repairs, and service on robotics and analytical instrumentation.
• Remote assignments involved with authoring validation of equipment and cleaning validation.
• Validate GCMS, LC, GC, FTIR instrumentation
• LIMS Development and programming

Confidential, 27 Wellington Road,RI

Field Service Engineer

• Dedicated on-site preventative maintenance, corrective repair, LIMS configuration, connectivity, calibration, refurbishment, and installation of multi wavelength random access clinical analyzers used for clinical diagnostics.
• Performed quality analysis on newly released instruments.
• Troubleshot mechanical robotic systems, repair, replace, install PCB, subcomponents, and perform electrical diagnostics, Interpret diagrams, schematics, perform onsite repairs on several platforms.
• Provided applications for chemistry and electrolyte testing.
• Travelled to site locations inclusive to the northeast seaboard and Midwest areas acting as the company specialist on the Confidential, Confidential, and Confidential .
• Directed scheduling, travel, part inventory and respond to calls for preventative, routine, and emergency services. Initiated companywide reduction for parts usage and provided cost reductions for all company travel.
• Provide engineering excellence for dedicated and custom onsite repairs, troubleshooting, corrective maintenance, installation, and received the company achievement award for outstanding service performance.
• Participate in production change, recall, and re-engineering assignments.
• Mastered service, troubleshooting, Reagent handling, and repair on the Confidential, Confidential, and Eon Analyzer.
• Achieved high customer satisfaction while meeting deadlines for on-time repairs.
• Worked expertly on chemical test methodology, applications, measurement, and troubleshooting LIMs data handling systems with reconfiguration, connectivity and installation master certification.
• Mentored customers, staff, and associates on handling problematic subcomponent failures. Provide efficient and effective solutions for customer complaint handling and resolution.
• Attended and completed company sponsored factory training on engineering for clinical instrumentation and data handling LIMs sub-systems.
• Completed GMP, SOP, and other CFR part 21 company training.
• Certified ISO 13485:2003 / ISO 9001:2000 & 21 CFR 820 quality management systems.
• Responded for cost reduction strategy, implementation of minimum inventory and parts reduction program.

Confidential,Fl

Field Service Engineer

• Provided multi-vendor direct services, applications, preventative maintenance, installation, corrective maintenance, calibrations, and qualifications on multiple brands of scientific equipment for major pharmaceutical corporations on the east coast.
• Validated process and procedures on solid dose equipment, laboratory and validation process.
• Calibrated in-line tablet counting equipment, induction sealers, and metal detection equipment.
• Repaired and troubleshot HPLC, GC, GCMS, LCMS, FTIR, and cell cytometry equipment.
• Performed routine equipment inventories using SAP and asset management systems. Maintain minimum trunk stock inventory to within quarterly expectations.
• Prioritized repairs to minimize customer down time and to maintain PM/PQ/IQ/OQ schedules. Proficient at QDS and generating customer reports for GMP requirements.
• Mastered Confidential Nelson Analytical, hardware, software, installation, and certification per part 21 CFR guidelines.
• Nautilus LIMS
• Reported all calibration results to senior metrology staff members and inform metrology of any non-compliance issues.
• Followed clean room production protocol, participate in chemical safety program, and ensure compliance of all CFR part 21 protocols.
• Mastered service, troubleshooting, and repair on multi-component Confidential HPLC systems.
• Validated solid dose equipment, centrifuge, and cleaning equipment and proficient on Confidential, Confidential, Confidential, Confidential, and Confidential .
• Achieved high customer satisfaction while meeting deadlines for on-time repairs.
• Mentored, monitored, and provided assistance to other new hires and fellow engineers.
• Trained on customer specific GMP guidelines and protocols.
• Authorized new procedures and implement new protocol for equipment validation.
• Attended and completed company sponsored training on maintaining Confidential hardware, software, LIMS, Confidential, and Confidential systems.
• Completed GMP, SOP, and other CFR part 21 company training.

Confidential, Hicksville,NY

Customer Service Engineer

• Served as Field Service position with a nationwide consulting firm specializing in water treatment, quality and testing on HVAC system fluids and controls.
• Specialty project coordination with the Port Authority of New York and New Jersey, medical institutions, colleges, and other major buildings in the metropolitan region.
• Provided comprehensive reporting, testing, and evaluations on cooling, heating, and building management systems.
• Coordinated and publish monthly technical service bulletins. Publish monthly technical service reports and provide feedback to customers with recommendations.
• Determined pricing, specify components and generate proposals for new projects.
• Maintained a database of results for routine customers and facilitate the implementation of a new data tracking and graphing system for laboratory results and reporting.
• Research new formulations, test procedures, and evaluate corrosion control systems.
• Performed field visits and service automated electronic test equipment.
• Maintained budget, manage financial data, and provide monthly target data.

Confidential,Garden City,NY

Customer Service Engineer

• Certified laser specialist for a firm specializing in skin esthetics.
• Prepared laser device for daily procedures.
• Operated, maintained, modified, and calibrated laser systems.
• Ordered supplies and specify new equipment.
• Developed budget, cost targets, audits on staff training, and performance reviews.

Confidential,Stillwater,MN

Field Service Engineer

• Served as Field Service Engineer for an international immunodiagnostics corporation specializing in clinical and reference laboratories.
• Provided Technical Services support role providing service and applications OEM robotic, semi-automated, automated serum and blood analyzers for in-vitro diagnostic testing.
• Provided onsite instrumentation, liquid handling equipment, robotics, reagent knowledge, installation, troubleshooting, electrical diagnostics, sales and support. Company LIMS expert with master project experience, installation, reconfiguration, testing, and compliance in accordance with FDA and International compliance protocol.
• Delivered customer assay correlation work and FDA compliance testing for quality assurance and CE compliance.
• Followed GMP protocol and procedures, assisted in providing operation and service manual updates.
• Demonstrated products through trade show exhibits and working with sales staff to offer high quality goods and services.
• Delivered technical on-site customer training and troubleshooting of assays. Repaired instrumentation and served as subject matter expert for assays, chemicals, antibodies and manual methods.
• Determined failure causes, analyzed equipment malfunctions, replaced, repaired and upgraded software and hardware, fluidic, electrical, opto-electronic and mechanical parts.
• Managed new equipment, lead training programs and performed product updates, improved instrument reliability by providing key program changes for assay updates and executed plans for critical hardware changes.
• Uncovered root causes of failure analysis through data sorting, manual comparison, and instrument performance characteristics.
• Continuously improved handling of instrument errors and provided solutions for customer complaints using flow charting and fishbone problem-solving approach.
• Managed East Coast Instrument Installation rate success and high satisfactions level through increased quality control and service excellence.

Confidential, Long Island,NY

Contractor

• Configured network interface and debugged system prior to launch target.
• Set up data interface for analytical instruments and automated product quality control system.
• Constructed systematic networking and parallel data input comparison.
• Collaborated with engineering and process staff on special devices and linkages. Linked multiple interfaces through standard personal, network and process computers internationally.
• Attended advanced product training courses and master certification program.LIMS master user and programming capabilities.

Confidential,New York,NY

Manager of Instrument Analysis

• Managed staff of five laboratory personnel and performed management tasks related to laboratory operations. Monitored and provided SOP and QA data for analytical instruments.
• Developed planning, quality control programs, and training schedules for key instrument utilization and performance operatives.
• Planned strategically, evaluated and recommended laboratory operations.
• Provided training to users on recommended operation and possible modifications of equipment to customize for research or academic uses.
• Maintained, calibrated, repaired and tested instruments, ensuring operational soundness and compliance with quality control criteria.
• Operated, serviced, maintained GCMS, IR, GC, FTIR, HPLC, LC, IC, NMR, GC-FTIR, UV/VIS, IC and other major equipment.
• Updated software and firmware. Interfaced, hardwired and routed T1, Ethernet and wireless devices. Established internal LIMS capability.

Confidential,Tuxedo, NY

Analytical Technical Service

• Provided technical services in the organic analysis laboratory, providing technical solutions for customers, processes, products and complaints.
• Analyzed samples in organic laboratory using gas, ion and liquid chromatography.
• Repaired, maintained, and serviced HPLC, Ion Chromatograph, Gas Chromatograph, and infrared spectrophotometer instruments.
• Analyzed organic and inorganic samples by Raman and infrared spectrometry. Corresponded with customers by telephone and in writing, and traveled to internal and external customers for follow-up and recommendations.
• Trained in TQM and GMP principles and procedures.
• Completed courses in advanced communication skills.
• Collaborated on LIMS data acquisition system and chlorophenol/dioxin laboratory EPA compliance program. Set-up monitoring program for clean room laboratory and Preparation of GCMS specimens for analysis.
• Maintained and repaired components of the Finnegan GCMS system for trace level detection of phenolics.
• Conducted sensor development and quality testing for mill and ambient testing program.
• Participated in the Mobile Environmental Research Laboratory (MERLAB) mill air quality evaluation program.
• Performed quarterly air compliance studies on mill data using SAS and other OEM software packages. Maintained company MERLAB through performing extensive field service repairs on air monitoring equipment and quality diagnostic tests on specialty gaseous emission analyzers.
• Handled on PE Nelson Analytical configuration and testing experience, total chrome master training.
• Performed mill-wide ambient monitor evaluations for hazardous gas detection. Served as quarterly safety inspector and conducted quarterly safety meetings.