Senior MES Functional Consultant

Rockwell Automation-posted 3 months ago
Full-time • Senior
MI
5,001-10,000 employees
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The Senior Manufacturing Execution Systems (MES) Functional Consultant is an important role in defining and developing the strategy and implementations for our Life Science clients' manufacturing information systems. You will become intimate with our FactoryTalk PharmaSuite® technology and tailor its implementation into our clients' environments to provide more reliable manufacturing in such a critically important industry. This is a remote position that reports to the Professional Services Consulting Manager.

  • Build partnerships at a functional requirement level with client counterparts.
  • Lead end-user manufacturing process discussions and process mapping by understanding the pharmaceutical manufacturing process in primary/secondary manufacturing of pharmaceutical products, Active Pharmaceutical Ingredient (API), Biopharmaceutical, Medical Devices, and like life sciences manufacturing environments.
  • Lead workshops to analyze our client's user requirements and design the appropriate solution that aligns to client needs and achieve ANSI/ISA-88 standards.
  • Write the Functional Design Specification to define what functions fit the standard application framework and what custom developed application code is required for site-specific business purposes.
  • Build migration strategies for clients to move from previous MES systems or from paper batch records into the PharmaSuite® technology.
  • Perform fit-gap-analysis and configure functional aspects and solution designs for commercial proposals and into solution delivery.
  • Define the integration strategy of the MES application to enterprise business systems, information management systems, and control level systems.
  • Author/review/implement project MES system validation plan (such as informal testing, authoring integration test protocols, formal testing).
  • Manage team expectations for using the application code in Master Batch Records (product manufacturing recipes) for internal partners or client staff to build the recipes specific to their manufactured goods.
  • Provide guidance on GAMP, GxP, FDA guidelines and best practices.
  • Be a mentor to technical and functional team.
  • Build new business growth and client success by participating in presales meeting.
  • Bachelor's Degree in Relevant Field.
  • Willingness to work weekends and holidays to meet customer project commitments.
  • The ability to travel to client sites. Travel can vary on assignment from 0% to 100% but can average 30% of the time.
  • Legal authorization to work in the U.S. We will not sponsor individuals for employment visas, now or in the future, for this job opening.
  • 12+ years of professional functional/technical experience related to software development and systems design and deployment.
  • A Bachelor's degree in a technical field related to information technology such as mathematics, engineering, computer science, or information systems.
  • Experience with FactoryTalk PharmaSuite® or other MES applications in life sciences.
  • Understanding of MES domain knowledge.
  • Background within the Life sciences/Pharmaceutical/Biotech/Medical Devices industries.
  • Abstract thinking ability for developing technically sustainable, modern, performant, as simple as possible, maintainable, and reusable solution designs.
  • Project management skills.
  • Understanding of cost estimation for solutions, including infrastructure, licensed software.
  • Knowledge of SDLC processes, automation systems and ERP.
  • Basic understanding in object-oriented programming in Java, C++, C#, JAVA development, JAVA Framework, J2EE App Server / JBoss, HTML5.
  • Knowledge in software configuration, validated software implementation (GxP and GAMP).
  • Health Insurance including Medical, Dental and Vision.
  • 401k.
  • Paid Time off.
  • Parental and Caregiver Leave.
  • Flexible Work Schedule where you will work with your manager to enjoy a work schedule that can be flexible with your personal life.
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