Senior Project Engineer, MES & Electronic Batch Record

Senior Project Engineer, MES & Electronic Batch Record (Direct Hire)

Greater Chicago Area, IL

Job Requisition: 6356

Description of Senior Project Engineer, MES & Electronic Batch Record:

The Senior Project Engineer is a hands-on engineer focusing on electronic batch release (eBR) projects as part of the company’s Pharmaceutical Manufacturing Execution Systems (MES) Competence Center. The position will assist the planning and implementation of information technology infrastructure.

Responsibilities for Senior Project Engineer, MES & Electronic Batch Record:

  • Support the Project Manager to effectively complete MES projects on time and within budget.
  • Design and implementation of MES, EBR systems and xIoT Platforms.
  • Assist in overseeing project processes including documentation, risk management and change control.
  • Draft and compile all URS, Design Reviews and other Qualification protocols.
  • Analyze requirements for Manufacturing Execution / electronic Batch Recording Systems
  • Create and configure MES recipes, especially for customizing the connection of MES systems to production lines and equipment
  • Implementation of MES and eBR training for end users as well as support for system testing 
  • Handle change control, risk assessments, work orders, SOP’s, AOF’s.
  • Test, document, and conduct end user training regarding shop floor system enhancements. 
  • Support the hardware systems being used by shop floor systems, including monitoring system health, maintain connected peripherals, application software patches, and maintaining overall system performance. 

Requirements for Senior Project Engineer, MES & Electronic Batch Record:

  • BS degree in Engineering discipline; PMP certification and/or Master’s degree a plus.
  • 5+ years engineering and project experience in control systems, process control techniques, automation technology, common programming languages or configuring a work flow automation platform.
  • 2+ years experience implementing a Manufacturing Execution System (MES) or electronic batch records (eBR) system within the pharmaceutical industry.  
  • Experience supporting Werum PAS-X eBR systems a plus.
  • Basic understanding of manufacturing processes within the pharmaceutical industry and ability to read construction and process drawings.
  • Experience supporting Project Managers in successful project delivery.
  • Excellent oral and written communication and conflict management skills.
  • Ability to travel 10%

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