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Senior Project Engineer

Act as the lead technical resource for our plant expansion program. You will take a lead role in the implementation of our new aseptic production capabilities. You will work with internal and external stakeholders to ensure the filling and packaging lines are properly defined, implemented, tested and fully functional prior to transition to commercial production.

Responsibilities

    • Manage vendors to complete all aspects of new equipment implementation including: FAT, SAT, Commissioning, and validation
    • Manage various internal and external stakeholders, including vendors, suppliers, and contractors
    • Provide technical advice and expertise to site engineering and production groups to facilitate planning and solve complex technical mechanical issues
    • Identifies program risks and develops strategies and tactics to mitigate/eliminate complexity
    • Develop, edit, and release internal technical documentation in support of new equipment installation
    • Provide planning oversight to project team from new equipment introduction to commercial readiness.

Qualifications

    • Degree/diploma in mechanical or manufacturing engineering. PEng preferred.
    • 5+ years experience in a regulated environment (medical devices, pharma, life science or similar)
    • Demonstrated experience with a large scale retrofit/new equipment installation program in a manufacturing setting
    • Experience writing detailed user requirement specifications (URS)
    • High proficiency in AutoCAD, MS Office, and MS Project
    • Strong business acumen – ability to understand business impact of technical/mechanic decisions
    • Serialization experience is an asset
    • Experience with FAT/SAT/DQ/IQ/OQ

Application Process

Application process: Please send your resume using the form below.

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