SR Principal MES Engineer, PAS X

The SR Principal Specialist MES is responsible as the project/design manager for MBR design activities across multiple sites in the region. This role coordinates the deployment related Production Execution Systems (PES) functions within each site PES team, area leadership, and between related departments. The incumbent interacts in a highly cross‑functional environment to ensure SAP and MES solutions support the needs of Production and Quality Management. This role assists the Regional Manufacturing Process Lead, Regional MES Engineer, and local PES Production teams with process improvement prior to phase deployment. Other duties will include providing informal leadership to less experienced design team members, resource planning, documentation of work, provide direction to other local team members, assistance, technical support and maintain compliance at both the local and global levels for MES implementation and sustainment. These initiatives may be functional area specific or cross functional in nature. Duties & Responsibilities Responsible for design management for MBR design activities at each site related to deployment of MES to all production departments. Responsible for MBR design activities include records for deployment to new production areas and may also support new launch/transfer of products into the deployed production areas. Manages and delivers projects and processes for Operations with quality which impact economic growth potential, reduce market risk and support site throughput outcomes and results to meet key performance indicators. Directly responsible for the expansion and development of MES across the organization in support of advancing and growing the business. Leads the creation and maintenance as needed of master recipes in SAP and master batch records in MES. Provides guidance for both PES and other Production related to best practices. Serves as BIAH representative for the PAS X Regional User Group consisting of various pharmaceutical and vaccine manufacturers utilizing and integrating MES. Serves as SME in all ERP functionality related to PE regarding usage of SAP, SAP Master Recipes, MES and with understanding of related workstreams. The technicality of this role assumes local and global support activities when needed. Leads and/or supports process improvement initiatives and project teams. Leads and mentors the lesser experienced team members with expertise to ensure appropriate documentation and procedures have been followed during the design process. Incorporates process improvement methodologies (i.e. 5-step method for problem solving, six sigma, lean manufacturing, etc.) in working with project teams. Identifies and formulates tactical solutions to assigned areas of focus. Responsible for regularly coordinating and communicating with support functions such as Production Planning, Quality Assurance, Maintenance, Engineering or other cross functional areas in support of process improvement and other maintenance activities to meet requirements and timelines. Responsible for leading/managing multi-site CAPA implementation, auditing and revision of standard operating procedures for compliance related to MES processes and MBR creation and updates. Responsible for overseeing the regular coordination and communication with support functions such as Quality Assurance, Maintenance, Engineering or other cross functional areas in support of CAPA implementation and process/documentation improvement activities. Creates, reviews, and updates OJT & MBR curricula and compliance requirements. Assists with planning, scheduling and performance of job task analysis of electronic record designers. Ensures Regulatory Compliance regarding process order data and batch records. Assists with regional change controls, BOM and planning recipe updates to ensure compliance and correct costing of products. Performs other duties as required. Requirements Bachelor’s degree in a STEM field, Business or related area of focus with a minimum of eight (8) years’ experience implementing MES activities, supporting production processes, and/or executing relevant functions in a cGMP manufacturing/operations environment or similar organization required. OR In lieu of degree, a minimum of twelve (12) years’ experience implementing MES activities, supporting production processes, and/or executing relevant functions in a cGMP manufacturing/operations environment or similar organization required. Minimum of two (2) years’ experience with PAS X or other MES related software required. Proven experience as a project manager including formal or informal leadership of project team. Demonstrated decision making, communication, planning and organizing abilities. Organizational change management experience is preferred. Relevant industry experience must be inclusive of a strong, working knowledge of MES, ERP and applicable systems. Must be proficient in MS office applications including Project, Word, Excel, Outlook, etc. Demonstrated knowledge of relevant production and/or packaging techniques and equipment. Demonstrated proficiency in applicable software applications utilized in production and/or packaging. A working knowledge of cGMP, EU and OSHA guidelines as they pertain to implementing process improvements to production and/or packaging equipment. Demonstrated ability to train others and complete OJT/training assessments. Ability to follow systematic continuous improvement methodologies and the willingness to identify, define and implement process improvements. Travel requirement of 30%. Eligibility Requirements Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required). #J-18808-Ljbffr