MES Engineer

Location: Caguas, PR, Puerto Rico
Date Posted: 09-01-2017
MES ENGINEER

 
Description
 
Seeking a MES Engineer with Werum / PAS-X experience to support the design and implementation of FDA Manufacturing projects. Manage very competing timelines, schedules and prioritize critical tasks. CANDIDATE MUST POSSESS REGULATORY EXPERIENCE IN THE PHARMACEUTICAL, BIOTECHNOLOGY OR MEDICAL DEVICES INDUSTRY.
Responsibilities
  • Provides IT expertise support to computerized systems, process equipment and automation systems during manufacturing operations (e.g., Manufacturing Execution Systems, Data Historians, etc.)
  • Specify, design, develop, document, test and implement manufacturing execution systems.
  • Supports the Manufacturing Execution System Data Management applications: MES, OSI PI, Maximo and/or SAP Interface.
  • Map existing manufacturing process (warehouse, equipment management & EBR) to MES
  • Design and deployment of MES systems to replace paper based or manual systems in a pharma environment.
  • Assess manufacturing processes and develop/configure Electronic Batch Records (EBR)
  • Implement MES solutions and integrate with ERP and control systems
  • Documentation of MES configuration and validation of EBRs.
  • Responsible for master data set up, system administration and related standard operating procedures.
  • Support planning, development, implementation, installation, troubleshooting, maintenance, qualification, validation and upgrade for computerized systems related to MES environment.
Skills and Qualifications
  • Good interpersonal skills and problem solving.
  • Solid understanding of the Manufacturing Execution System architecture and security.
  • Experience installing, configuring, validating Manufacturing Execution Systems.
  • Proven experience with MES project execution (requirements analysis, design definition, design review, software development and review, solution implementation, testing and acceptance, traceability).
  • Knowledge of ERP (including integration with SAP) a plus
  • Fully bilingual: oral and written
  • Takes initiative, works with minimum supervision
  • Leadership and team-building
  • Eager to demonstrate value by sharing knowledge with others
  • Excellent verbal and written communication
  • Analytical problem solving
  • Driven by results on time
Requirements / Qualifications
  • BS degree with minimum of 5 years overall experience, with minimum of 4 years MES project experience.
  • Deployment experience with plant floor/Manufacturing Execution Systems (MES) solutions (e.g. Syncade, Werum PAS-X)
  • RELATED EXPERIENCE IN THE PHARMACEUTICAL, BIOTECHNOLOGY OR MEDICAL DEVICES INDUSTRY.
Integrated Technology and Compliance Services is an Equal Opportunity Employer
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