Manage Change Controls, CAPAs, Deviations, NOEs, and capital projects.Validation activities including temperature mapping, system audits, and review policies.Develop, evaluate, improve and implement manufacturing methods, utilizing knowledge of product design, materials and parts, fabrication processes, tooling and production equipment capabilities, assembly methods and quality control standards.Analyze, audit, and improve the manufacturing process by coordinating modifications, driving corrective actions and troubleshooting new and existing equipment and assessing action effectiveness. This includes scope development, engineering calculations, evaluating risks and alternatives, estimating costs and schedule, arranging for implementation of the work, supervision of the completion of the job, and prepare process and equipment protocols along with final summary reports.Use technical knowledge and skills to ensure the best methods and processes available are utilized at the best value possible for devices and pharmaceuticals by developing projects which drive lean and 6σ initiatives across all manufacturing processes while working closely with all other cross functional team members to support team and plant wide goals.

Manages Capital Projects including identifying customer requirements, developing project scope, project plans, developing schedules and budgets to execute and complete the project. Provides process engineering to support operational and business needs in the development, deployment and testing of automation solutions. This includes compressed gas and pharmaceutical unit operations, resolving operational process issues, environmental, safety and technical documentation management, and long range investment planning.Provides technical support to manufacturing, validation, R&D, business development, and Quality by performing technical research, engineering development, good engineering practice, and cGMP in a broad spectrum of pharmaceutical operations (drug and device) including operational systems, new innovations, and business development opportunities.Coordinates the modification, troubleshooting, and remediation of existing equipment as requested by production, operations and validation team members. This includes scope development, engineering calculations, evaluating risk and alternatives, estimating costs and schedule, arranging for implementation of the work, and supervision of the completion of the job.Generate and Compile Fundamental System Requirements, and Design Specifications, Standard Operating Procedures, Validation Protocols and Commissioning Documents.Execute validation and commissioning documentsDevelop and manage Vendors/Architectural & Engineering Firm/Consultant contract agreements and interactions insuring capitol project deliverables meet project design objectives and deliverables in compliance with cGMP requirements.Develop an internship/co-op program to produce additional resources that provide valuable contributions to Mallinckrodt and cultivate potential employees.

Manage Quality Assurance for multiple multimillion dollar Army Corp of Engineer and City of Mandeville projects simultaneouslyVerify that all work is performed in compliance with project contract and technical specificationsReviewed contract specifications and drawings for Construct-ability issues and provided recommendations to the Contracting Officer and Resident EngineerVerify the accuracy of contractors’ monthly pay requests, budgets, and schedules Conduct preparatory, initial, and final inspection meetings for each feature of work to guarantee the work is performed in accordance with the contract specifications Technical review of contract documents, including shop drawings, submittals, Requests for Proposals (RFPs), Requests for Information (RFIs), and Change Orders (COs)Ensure that appropriate documentation is created and maintained to support the timely submission of progress reports, testing, features of work, and paymentGenerate drawings in accordance with designers' instructions to illustrate changes to the contract specificationsCreated drawings, requests for proposals, and specifications based on clients needsProvided onsite technical supportCoordinated with utility companies to relocate utility lines during construction.Conducted weekly meetings with contractors to ensure projects remained on schedule.Managed and trained on-site inspectors. Various other management and engineering support tasks as assigned

Assisted in development of Solar and Wind Turbine SystemsTroubleshot problems in preexisting pneumatic and electric systemsSized new systems based on customer parameters Develop new product concepts

LSU - Assisted in research at LSU on turbine blades in a high temperature, high pressure environmentS&B - Investigate problems and methods to help ensure the safety of employees

Repaired, calibrated, installed, modified and tested several different types of instrumentation used in blood testingRead blueprints and schematics to troubleshoot instruments and determine acceptable locations for installationTrained hospital and clinic employees on the operation and maintenance of their instrumentationGuided hospital and clinic employees over the phone on how to make repairsResolved a wide range of customer problems, applying diplomacy and creativityFollowed up by phone to verify customer satisfactionMaintained an inventory that was crucial to my ability to performDemonstrated safety and proficiency while working with biological hazards