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Project & Process Engineer

Req #: 170005ND_en
Location: Oued Ellil, TN
Job Category: Administration Services
Date Posted: 8/11/2017 10:45:44 AM
Baxter International

Description

  • Lead New Product Introduction or Transfer projects with R&D team.
  • Author Installation, Operation, and Performance qualification protocols and reports:
  • Identify the critical parameters and instruments in these protocols and create proper tests.
  • Coordinate the Equipment, Product, Process and Facility Qualification activities as required.
  • Support and implement plans to ensure all activities are done within Baxter is compliant to current regulatory requirements.
  • Provide training on qualification topics as required.
  • Review, initiate and recommend changes, as applicable, to different documents and Validation Master Plan for equipment and facilities qualification.
  • Participate in the investigations, the audits and the improvement initiatives.

Qualifications

  • Bachelor degree in Industrial or Mechanical Engineering.
  • Minimum of 2 years’ experience in project management.
  • Experience in validations activities and documentations.
  • Knowledge of change control and qualification concepts.
  • Knowledge of GMP.
  • Skills of Microsoft Office software’s (Word, Excel, PowerPoint & Outlook)
  • Good command of the English language, both written and verbal.
  • Communication skills including verbal, written and presentation skills
  • Ability to work effectively in a team based environment
  • Problem solving and critical thinking skills.
  • Knowledge in statistical techniques and tools.

Preferred Requirements:

  • Medical device experience.
  • Microsoft Project.
  • Minitab.
  • Familiarity with Quality System Standards - ISO 9001 and ISO 13485.
  • Green Belt certification (or equivalent) would be an asset

 

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