Joseph — Electrical Engineer

11/17 - Present, Electrical Engineer, Piramal Critical Care, Bethlehem, PA Responsible for all aspects of electrical from power to automation for entire facility: - Provide training and prepare new programming related to PLC and HMI equipment - Manage automation projects - Manage internal and external resources assigned/contracted to perform installation, commissioning and qualification activities. - Insure GAMP compliance with all automation systems - Provide technical expertise and training to in house and contracted technical staff - Oversee development, implementation and maintenance of data collection systems including assisting users in getting easy access to data - Review new equipment electrical specifications - Responsible for control systems design, specification, programming, simulation and testing, and start up assistance - Responds to emergency automation and electrical situations - Work closely with the plant instrument technician in installation, troubleshooting, checkout, validation and start-up of new instrumentation. - Develop URS, FRS and other protocols and documents as required, including IQ, OQ, PQ protocols. - Insure accurate completion of all validations documents such as IQ, OQ, PC protocols. - Assist in representing the plant during factory acceptance testing (FAT) of equipment to be supported, maintained or calibrated. - Design, develop, manage and complete instrument and automation projects as required. - Insure FDA, cGMP compliance for all metrology and automation related records

5/15 - 10/17, Project Manager, Equipment Sales & Integrated Projects, Fedegari Technologies, Sellersville, PA - Performed all project management duties related to manufacturing FDA/cGMP compliant moist heat sterilizers, dry heat sterilizers, washers, vaporous hydrogen decontamination system, sterility test cabinets, isolators, and automated integrated handling systems for the pharmaceutical industry such as: production cost estimation, control system design, mechanical system design, installation, and on-site startup and testing. - Oversaw complete lifecycle of system development starting at receipt of purchase order through design phase, manufacturing phase, testing phase, installation, and startup phase at customer's facility, and training of customer staff. - Act as central point of contact for all clients after receipt of purchase order. Provide coordination of activities between clients and R&D and After Sales Groups as needed. Work with clients and corporate engineering group to address special custom designs

7/07 - 5/15, Sanofi-Pasteur - Swiftwater, PA Deputy Director, Facility & Utility Systems - Regional GEM Projects, 8/14 - 5/15 - B77 Formulation, Filling & Packaging Facility for Live Attenuated Viral Vaccines - Review and approval of all aspects of the design and installation of all utilities. - Manage project design engineering team to assure that all relevant codes, regulations and guidelines are appropriately followed. - Manage Installation, Commissioning and IOQ Project Managers for all facility and utility systems. - Review and approval of all aspects of the design and installation of all process equipment within the boundary of the formulation phase of the manufacturing process. Senior Manager, Site Project Management & Project Controls, 10/13 - 8/14 - Develop project scope for the upgrade of two packaging lines for process optimization to align with new JIT corporate strategies. - Work with vendor team to define the scope of work for the renovation of existing syringe blister packaging line to better facility JIT manufacturing practices. - Manage project to schedule keeping costs under control yet assuring all project deliverables meet quality requirements utilizing site Six Sigma philosophies. - Conversion of office space into lab space for additional in-process testing to facilitate process optimization for influenza vaccine manufacturing. Senior Manager, Engineering/C&Q Best Practices, 7/07 - 10/13 - Coordinate the development of all C&Q related documents for all site process/utility/facility/HVAC equipment/systems in order to support process improvement and optimization project - Develop a project strategy to utilize "disposables technologies"; increasing the use of plastic tubing in lieu of traditional stainless-steel tubing for process optimization and sterility assurance. - Coordination and oversight of multiple C&Q execution activities. - Manage 2 teams of contract resources with upwards of 25 resources total. - Manage contract project managers for the successful and timely completion of all C&Q activities for multiple facility renovation projects/ - Work as an integral part of the project team to meet the project goals for overall quality and timeliness while assuring that Quality & Compliance responsibilities are never compromised utilizing concepts of Six Sigma. - Continue the support and development of a new paradigm C&Q strategy (ASTM E2500) to streamline all project C&Q activities to align with new Six Sigma process strategies. - Provide support for the Global Quality Audits related to re-licensing of site manufacturing facilities

3/07 - 7/07, Senior Project Manager, Day & Zimmermann Group, Philadelphia, PA - Project management support for the validation of the new Sanofi Pasteur, Swiftwater, PA, Building 37 Flu filtration suite (1208). - Maintain daily project status updates and assisted in the resolution of individual project deviations and discrepancies. - Manage project execution team (5 engineers) for the qualification and validation of all systems for the new filtration suite

5/05 - 3/07, Manager Process Validation Group, BE&K Engineering Inc. (BioPharm Group), Newark, DE - Manage a multi-discipline project team (5 engineers) for the commissioning and validation of a new API facility for constructed for process improvement and to support corporate JIT manufacturing objectives. - Developed multiple project specific Validation Master Plans (VMPs). - Coordinated the development of all Validation and Qualification documents. - Oversaw the execution of all Validation and Qualification documents (3 technical writers). - Developed and maintained Project Schedule for the delivery, installation, start-up, commissioning and qualification of the new facility with coordination from client representatives in harmonization with Six Sigma core objectives

12/03 - 5/05, Validation Project Manager, Independent Consultant - Managed the conversion of an existing R&D facility into cGMP compliant facility for the production of pharmaceuticals for Phase 1 and Phase 2 clinical trials, utilizing Six Sigma concepts and strategies. - Managed the project team (6 engineers) to validate various equipment related to this facility conversion. - Acted as central point of contact on all issues relating to the operation and validation of all automated systems

9/01 - 12/03, Validation Project Manager, Foster Wheeler USA Corporation, Clinton, NJ - Responsible for managing a team of 5 engineers to develop and execute protocols for manufacturing processes, cleaning, facilities, cold storage, sterilization, and equipment; analyzing data and preparing reports; assessing new equipment and technologies. - Act to ensure compliance with FDA regulations and cGMPs, and acting as a client representative during FDA audits. - Managed multi-disciplinary project team (10 engineers) tasked with the development and execution of Installation & Operational Qualification Protocols for various equipment/systems (i.e.: reactors, dryers, HVAC, etc.) for a new JIT manufacturing facility

9/00 - 9/01, Project Control Manager, Patterson-Kelley Co., East Stroudsburg, PA - Project management duties related to manufacturing of FDA/cGMP compliant dry powders and fine solids processing equipment for the pharmaceutical, foods, and chemical industries. - Duties: production cost estimation, control system design, mechanical system design, installation, and on-site startup and testing. - Oversaw complete lifecycle of system development starting at receipt of PO through design phase, manufacturing phase, testing phase, installation, and startup phase at customer's facility, and training of customer staff on the proper operation of equipment

8/99 - 9/00, Project Manager, ABEC, Inc., Bethlehem, PA - Project management duties related to manufacturing of FDA/cGMP compliant bioreactors, fermentation units and CIP systems for the pharmaceutical industry. - Duties: production cost estimation, control system design, mechanical system design, installation, and on-site startup and testing. - Oversaw complete lifecycle of system development starting at receipt of purchase order through design phase, manufacturing phase, testing phase, installation, and startup phase at customer's facility, and training of customer staff on operation of equipment. - Manage a project team to incorporate the use of plastic tubing in lieu of traditional stainless-steel tubing for process optimization, added sterility assurance and quicker batch change over time

1/97 - 8/99, Automation/Electrical Engineer/Radiation Safety Officer, Essroc Cement Corp., Nazareth, PA - Maintenance of the process control (PLC and MMI) network for two cement manufacturing facilities and one cement grinding facility in Nazareth, PA. - Managed multiple capital projects related to the plant wide automation systems (4 engineers). - Managed 12 union electricians/instrument technicians as well as 10+ independent contractor electricians/instrument technicians

2/89 - 1/97, Sr. Instrumentation Specialist / Sr. Project Specialist, Organon, Inc., West Orange, NJ - Became familiar with the company's plastic extrusion process while working with packaging department management and vendor resources for the implementation of a major blister packaging line. - Worked with vendor in order to develop list of project expectations and deliverables for the new blister syringe packaging line. - Gained experience with ISO 9001, cGMP, and Class 100 aseptic filing

5/86 - 2/89, Field Service Engineer, Nova Electric Manufacturing Co. - Bergenfield, NJ - Installed and repaired uninterruptible power systems, frequency converters and voltage inverters in the field and within the factory. - Led project teams for the design, fabrication, installation and start-up of custom design frequency conversion equipment for SEPTA railroad. - Managed contract resources at customers' sites where services were required to be performed by local resources