Project Manager in Oil & Gas and Biotech Industries.

Contractor responsible for managing several multi-faceted equipment, validation and product projects to produce over-the-counter (OTC) and prescription medications in accordance with FDA GMP regulations for a leading global Pharma company.Successfully led design projects for new and upgraded Pharma industry equipment using SolidWorks CAD to illustrate designs. Worked with multi-disciplinary teams and outside vendors to commission and validate equipment/processes on time and with supporting QA documentation.Conducted oversight of the engineering and validation efforts on a converting/pouching machine to produce a leading transdermal product. Coordinated new product introductions including material changes and prototype production.Supported equipment and processes by delivering validation documents including, User Requirements Specification (URS), Instrument Criticality Assessment (ICA), Failure Mode and Effects Analysis (FMEA), Installation/Operational/Performance Qualification (IOPQ), Standard Operating Procedures (SOPs), and Work InstructIons (WI). Produce Investigational Protocols (IP) and Final Reports for a variety of products by applying statistical methods to critique data.

Technical point of contact for a global project that saw the implementation of third-party hardware and software into products over a 12 month period. Consistently interacted with engineering, manufacturing, supply chain and purchasing functions in order to evaluate prototype components by devising and running performance and endurance engine tests. Responsible for ensuring efficient coordination with third-party project lead, planning and scheduling tasks, as well as general project management from project start-up to delivery of working hardware. Regularly chaired meetings to present the results back to the project team.Managed and oversaw the work of 5 technicians running multiple test beds to develop engine calibrations to meet exhaust emission requirements and aggressive fuel efficiency targets. Developed strong working knowledge of dynamometer and emissions equipment, engine control software structure and calibration tools. Conducted transient and steady state testing and analysis of the results to produce calibration iterations until product objectives were met and according to program timing deadlines.Evaluated engine components for design and manufacturing defects. Prepared issue reports for advancement through the company’s quality assurance system and participated in FMEA’s.Delivered endurance tests required for engineering sign-off of various products. Responsible for coordinating field installation, data acquisition, and overseeing the budget, timing and final results of the projects.

Delivered fuel efficient and U.S. EPA-compliant engine ratings on time and to specification for high-volume, multi-million dollar engine program customers.Programmed data acquisition systems and analyzed data using AVL Cameo model optimization based on measured engine responses.Highly-proficient in ProE Wildfire CAD. Consistently released drawings according to company processes, conducted hand calculations, designed new components, completed FMEA’s and created innovative valvetrain device now under patent.Successfully conducted modal, forced-vibration and fatigue analysis of engine systems and components, including discovering and rectifying vibration problem with common rail fuel systems using Abacus CAE and FE Safe fatigue software.Built and ran engine and machine-level thermodynamic models using Matlab and Simulink, resulting in reduced company labor costs and savings upwards of $100,000 due to less physical testing time.