Tuesday, 20 January 2015

Techno-Functional Consultant for S88 based Recipe Development and Management Program for Medical Devices Industry


Job Title
Techno-Functional Consultant for S88 based Recipe Development and Management Program for Medical Devices Industry
Relevant Experience
  • 8-10 years of professional experience
Education
Minimum Bachelor's degree in Engineering, Science, or a related discipline
Duration of assignment
12 months
Work Location
New Jersey area
Technical/Functional Skills
  • At least 1 large implementation experience in defining standards based recipe content and common nomenclature on an automation platform (Wonderware, InBatch and ArchestrA preferred, Rockwell or Siemens etc)  
  • Thorough and hands-on knowledge of implementing S88 standards
  • Experience in defining standards based reusable libraries and process actions
  • Experience with any Pharma PLM (Dassault BIOVIA, Oracle Agile) is strongly preferred
  • Understanding of diverse regulations (FDA, CFR etc) and managing compliance documentation for the project
  • Understanding of R&D to Manufacturing technology transfer process
  • Understanding of challenges in Medical Devices Industry from R&D to commercialization
  • Microsoft Office (Word, Excel, PowerPoint, Outlook)
Experience Required
  • Strong communication (verbal and written) skills is a must
  • Experience with Wonderware InBatch, InTouch, ArchestrA is strongly preferred
  • Experience in developing a global standards library and experience with Wonderware is strongly preferred
Roles & Responsibilities

·         Provide technical direction to develop Recipe Management framework based on S88 standards and testing of process actions library and components
·         Ensure compliance to all regulations (CFR, FDA, QSR) as identified by SQA/SQC
·         Manage and update compliance documentation
·         Ability to baseline current practices around content development and data flow
·         Ability to baseline variation for manufacturing equipment and lines
·         End user training on S88 standard adoption and proliferation
Generic Managerial Skills
  • Knowledge of project management processes
  • Ability to plan, prioritize and execute complex project deliverables
  • Must have the ability to assess and mitigate technical risks
  • Strong decision making and problem solving skills