Pillar5 Pharma Inc.
The Senior Project Engineer will 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 our new packaging lines are properly defined, implemented, tested, and fully functional prior to transition to commercial production.
- Manage vendors to complete all aspects of new equipment implantation 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 risk 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 AND REQUIREMENTS
- 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/mechanical decisions.
- Serialization experience is an asset.
- Experience with FAT/SAT/DQ/IQ/OQ.
Job Types: Full-time, Permanent
Salary: $90,000.00-$110,000.00 per year
- Employee assistance program
- Extended health care
- On-site parking
- RRSP match
- Vision care
- 8 hour shift
Work Location: One location
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