Project & Process Engineer
Req #: 170005ND_en
Location: Oued Ellil, TN
Job Category: Administration Services
Date Posted: 8/11/2017 10:45:44 AM
- 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.
- 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.
- Medical device experience.
- Microsoft Project.
- Familiarity with Quality System Standards - ISO 9001 and ISO 13485.
- Green Belt certification (or equivalent) would be an asset