SUMMARY:

• Five (5) years’ experience with facility - Utility systems including boilers, chillers, compressed air, clean water, electrical distribution systems, UPS, etc.
• Eight (10) years of project engineering experience. Handle up to $1 million. Manage complete project cycle including budget justification, generation of bid specification, vendor selection, integrated system testing, startup/ commissioning support, system acceptance, validation, including supervision of other engineers.
• Equipment Validation and CSV in Biologics and Bio-Pharmaceuticals environments .
• Extensive experience with field Instrumentation including selection, calibration, loop testing and commissioning of devices like sensors, motors, drives, valves, weigh scales, and DCS systems etc.
• Familiar with Electrical power systems. Handled tasks like load analysis and upgrade, grounding, UPS, control system interface, start up and commissioning.
• (15) Years of experience within the pharmaceutical/chemical industry.
• Six (15) years of Commissioning and Control System Validation experience, with IQ, OQ, PQ documentation.
• Troubleshoot DCS Software/Hardware problems.
• Experience executing Recipes, Phases, EM’s and CM’s logic on Delta-V DCS System
• Working knowledge of the following standards GAMP5, IOS-9000,9001,FDA 21-CFR 210,211,S-88,Gamp and cGMP, ASTM E

SKILL:

PLC/DCS SYSTEM: Allen-Bradley ABB Mod300, Advant, OWP, Provox, Delta-V

Networking OS: Windows/NT,VMS,UNIX

Software Application: MS-Word, Excel, PowerPoint, Envox, Proflex, SAP, Oracle Server, SQL, Lotus-Notes

Hardware: Sr-90 controller s VME, HP-workstations, Advant Controller s, Dec-workstation etc. Provox, Delta-V

EXPERIENCE:

Confidential, TX

Sr. Delta-V Validation Engineer

Responsibilities:

• Provided quality reviews site-wide for utilities systems, assessments , specifications, commissioning qualification and final reports documentations.
• Create and execute IQ,OQ,PQ test cases for utilities equipment used Fujifilm facility Compressor Dry Air (CDA), Reverse Osmosis Deionization (RODI), Water For Injection (WFI), CO2, O2 and N2.
• Generate and process deviation/summary reports for protocol executions.
• Train validation engineers in their area of responsibilities

Confidential, Niagara Falls, NY

Sr. SAP PM Engineer

Responsibilities:

• Part of a team of consultants developing a site wide spares part program and preventive maintenance program in and around Facility and Paper Machine.
• Heading a site-wide audit analyzing SAP DB functional locations, equipment and materials to see if spare parts are documented correctly in SAP.
• Reviewing/making corrections SAP DB to ensure equipment spare parts are documented complete.
• Train new employees in areas of responsibilities.
• Make project recommendations to improve site-wide spares part program.
• Develop design spec that use for SAP changes.

Confidential, Buffalo, NY

Sr. Renovation Manager

Responsibilities:

• Provide all leadership activities related to home improvement projects for the company.
• Lead projects for plumbing, electrical, drywall, masonry and kitchen/bathrooms.
• Hired and train new employees in areas of responsibilities
• Responsible for and bill of materials related to company projects.
• Hired all subcontractors for projects.

Confidential, Oceanside, CA

Sr. QEV DELTA-V ENGINEER

Responsibilities:

• Provide leadership, guidance, and direction to staff consistent with Cgmp and company corporate quality governance.
• Determines validation requirements based on risk assessment.
• Responsible for all Quality department change records(CR’s) reviews for test protocols DQ,IQ,OQ,PQ and requalification activities.
• Provided to all new contract Quality Engineers that join the department.
• Work in an Quality environment that took a risk base approach toward Validation.
• Provided pre-post reviews for Delta-V and MES design, Validation and quality documentations.
• Reviews all commissioning, deviations, interim reports and final reports close outs.
• Review all departments TM’s, RMR and RA in line with VMP.
• Working knowledge of applications Trackwise, Valtracker, Doclink |EDMS, Livelink and gMail.
• Provide site­-wide quality reviews for the Syncade MES control system that supported commissioning and qualification executions effords.

Confidential, RI

Sr. DELTA-V VALIDATION ENGINEER

Responsibilities:

• Attend daily status update meeting for executing validation master plan.
• Review risk assessment and specification documentation for protocol qualification development.
• Draft commissioning and protocol qualification documentation documents.
• Provide protocol executions on the Delta-V DCS System.
• Closeout protocol deviations errors.
• Generate interim, summary and final reports after qualification.
• Equipment validation of bioreactors.

Confidential, LOS ANGELES, CA

Sr. DELTA-V VALIDATION ENGINEER

Responsibilities:

• Attend high level shutdown daily projects meeting to update management on projects status.
• Protocol executions in a simulation and production shutdown start-up environments.
• Review specification documentation (URS,FS,DS.SDS,HDS,TA,RA) SOP’S P&ID and test plans for project readiness.
• Draft qualification and commissioning documentation for software/hardware executions.
• Process and closeout deviations and PGE’s after protocol executions.
• Generated interim, summary and final reports after IQ, OQ PQ executions.
• Executed OQ protocols on an as needed basis.
• Documented and closeout all PGE’s.
• Author/executed OQ protocol for EBR reports.
• Equipment validation of Blood Plasma Pooling Tanks and Transfer Panels.

Confidential, PA

Sr. DELTA-V ENGINEER

Responsibilities:

• Provided configuration shakedown for process area’s for upstream and downstream areas.
• Generated Field Modification Request from configuration shakedown testing.
• Reviewed P&ID and IQ, OQ, PQ protocols for project scope.
• Generated test plans from FAT and SAT testing where deviations accrued.
• Verified and troubleshooting Delta-V hardware commissioning during process cell startup.

Confidential, HOPKINTON, MA

Sr. DELTA-V VALIDATION TEST ENGINEER

Responsibilities:

• Review and red-line P&ID’s Drawing.
• Review and red-line IQ, OQ and PQ Protocols.
• Test and validated CM’s, EM’s, Phase, and Recipes logic.
• Generate Deviation Logs and Change Request reports.
• Review and edit URS, FS and DS.
• Made configurations changes per design specification.
• Troubleshoot and analyze configuration/software problems and correct them.

Confidential, Portsmouth, NH

Sr. DELTA-V SOFTWARE TEST ENGINEER

Responsibilities:

• Organize and develop test cases in a R&D/Simulation environment to begin configuration testing for the Confidential Project.
• Test control module class to insure CALC, ACT&CND block expressions parse correctly.
• Program and validate control module class general items in configuration examples scan rate, alarm parameters, history collection and DS annotation etc.
• Test EM Module Class SFC run logic, stop logic, abort logic, and hold logic and failure logic.
• Tested and trouble-shoot Batch Node operations, unit procedures and procedures
• Tested all Phases in upstream and downstream production areas.

Confidential, EXTON, PA

DOCUMENTATION SPECIALIST

Responsibilities:

• Review project documentation for any errors (Ex.DS, FS, HDS, URS, etc.)
• Review and edit design spec for accurate and incomplete information.
• Compared URS documentation against all design spec to insure customer requirements was meet.
• Develop RTM Requirement Traceability Metrics for URS and Design Spec traceability.
• Reviewed/tested and executed Wonderware graphics per P&ID drawings.

Confidential, SANFORD, NC

Sr. VALIDATION ENGINEER

Responsibilities:

• Responsible for OQ Protocol executions and Dry Sequence Testing for Delta V phases used in the manufacturing process of pharmaceuticals (Ex. Buffer Prep, Media Prep, Fermentation, Chemistry and Purification).
• Documented Red Line items and Punch list items that highlighted deviations between Code, Detail Design Spec., Functional Spec. and OQ Protocol documentation. Edited OQ, FRS, and DDS documentation for rewrite.
• Resolved Protocol Non-Conformance Reporting and Protocol error’s with Protocol Writers, Technical Services and Engineering to correct deviation error’s found during my QO Testing.
• Provided technical review for Delta-V phases before testing began to ensure high integrity of QO Protocol, DDS, FS and code to minimize Test deviations.
• Equipment validation CIP skids, Media ultrafiltration and Fermentation.

Confidential, BUFFALO, NY

MAINTENANCE CONSULTANT

Responsibilities:

• Part of a team of consultants developing Asset Productivity Improvement Program for manufacturing facilities incorporating Reliability Center Maintenance elements.
• Upgraded their legacy system (3MCS) to SAP. Made recommendation for their SAP PM module that would improve API program metrics.
• Designs Predictive Maintenance Program for critical identify equipment to improve equipment Uptime and decrease Maintenance cost.
• Analyze problem equipment using Reliability Technique’s RCFA, FMEA and Logic tree. Develop measuring and monitoring metrics for equipment in program as part of a company’s Six Sigma business plan.

Confidential, PITTSFORD, NY

VALIDATION CONSULTANT

Responsibilities:

• Provide startup and commissioning services for automation control systems/HVAC systems for pharmaceuticals manufacturing processes.
• Execute IQ/OQ/PQ DST protocols for DCS Systems Delta-V/Provox for validation projects.
• Develop Maintenance Instructions and SOP’s for capital automation equipment.
• Document and report all PNR’s to Technical Services and Engineering for executions corrections and reruns.

Confidential, KING OF PRUSSIA, PA

Sr. VALIDATION ENGINEER

Responsibilities:

• Responsible for the validation phase for the Fisher-Rosemount DeltaV DCS systems used in production.
• Tested and executed test plans for operation code verifications.
• Generated and documented error logs that showed deviations from actual tested code.
• Validated control system display graphics (static and dynamic).
• Reviewed Standard Operating Procedures for Dry Sequence testing for Bioreactors, SIP, and CIP testing.
• Reviewed/tested and executed Wonder ware graphics per P&ID drawings.
• Equipment validation of fermentation, Media, and Buffer.

Confidential, ALLENTOWN, PA

MAINTENANCE MANAGER

Responsibilities:

• Responsible for developing corrective and preventive maintenance programs design to minimize downtime and enhance production for Lithium Niobate and Indian Phosphate silicon wafers
• Provide analysis to technical problems, including root cause analysis, efficiency improvements, operations performance and process dynamics.
• Assesses technology d Confidential to identify projected maintenance needed for reliability and availability improvements and cost saving.
• Responsible for all the hiring, development and of skill trade support staff.

Confidential, ROCHESTER, NY

Sr. SYSTEM CONTROL ENGINEER

Responsibilities:

• Provided level-3 engineering support for the configuration of hardware and software applications.
• Supported ABB DCS systems Mod300 and Advant product lines.
• Provided expertise and guidance for equipment modifications, repairs and upgrades identified by d Confidential obtained from technologies associated with Corrective and Predictive Maintenance programs.
• Provided onsite and remote support
• Analyzed system and development networking configurations (hardware and software) for communication problems with configured devices.
• Developed and trained field support staff (sales/marketing) for the implementation and application of the ABB DCS Systems.
• Analyzed and configured Oracle Server writing SQL programs

Confidential, ROCHESTER, NY

Sr. FIELD PROJECT ENGINEER

Responsibilities:

• Troubleshoot and analyzed configuration/application software for Provox DCS System.
• Provided onsite support and at customers site’s 
• Implemented startup and commissioning services for million dollar projects.
• Provided onsite root causes analysis for system and equipment problems.
• Developed/supported maintenance contracts for our area customer sites.
• Provided for new field Engineers in area of responsibilities.