Job Information
Körber Pharma Software, Inc. Senior MES Consultant in Parsippany, New Jersey
Senior MES Consultant - Parsippany, NJ (telecommuting permitted). Design, develop, install, test, and maintain enterprise-wide Manufacturing Execution Systems (MES) applications. Perform systems management and integration functions within a FDA regulated environment in connection with software development lifecycle (SDLC). Analyze business needs to determine feasibility of current PAS-X design or need for enhancements to current systems to meet clients’ needs. Support the formulation of functional specification activities with product demonstration and translate user requirements in to change specification for the technical team’s design of technical specifications. Develop and document user requirements, functional specifications, detailed design, traceability matrix, standard operating procedures (SOPs), installation instructions, and other system-related information. Configure PAS-X (MBR Design in the areas of work instructions, equipment management, user rights administration and configuration profiles) in accordance with corporate and/or client functional needs, requirements, quality control parameters and standard operating procedures. Develop investigative queries and reports, document and revise test procedures and quality standards. Perform testing (unit testing, integrating testing, acceptance testing) against developed specifications. Provide technical guidance for system troubleshooting and implementation. Provide support and training to end-users. Must have eighteen (18) months of experience (in any occupation) in developing, configuring and deploying PAS-X MES system specifications, including supporting functional specification activities with product demonstration and translating user requirements into Change Specification; Provide support and training to end-users; Perform testing (unit testing, integrating testing, acceptance testing) against developed specifications AND knowledge of PAS-X Manufacturing Execution Systems (MES), software project life cycle (SDLC), object-oriented design, GAP Analysis, enterprise application development and maintenance, pharmaceutical manufacturing, including FDA Regulation, ICH Guidelines, GAMP, EMEA and EPA requirements, OpenRoad GUI software development, customizing complex software, and the following programs: Oracle, C++, MSVC 6.0, Visual Basic, JAVA, XML, TCP/IP and OPC. May work at the Parsippany, NJ headquarters or telecommute from anywhere in the U.S. Approximately 10% travel required to unanticipated client sites throughout U.S. Send resume to Caryl Webb, Körber Pharma Software, Inc., at caryl.webb@koerber.com. Refer to job code: SMC/py. EOE