Astellas Pharma Facilities Engineering Manager in Seattle, Washington
Universal Cells is focused on the development and commercialization of stem cell and regenerative medicine therapies. We conduct clinical-grade gene editing of stem cells and have a major effort in R&D. We design and produce stem cells that avoid rejection, and we engineer cells with improved therapeutic properties, all through our world-class gene editing platform.
Our goal is to provide cells for regenerative medicine applications that can treat all patients. Through internal R&D and our corporate partnerships, we are pursuing a diverse range of disease indications, including blindness, cancer, vascular insufficiency, and autoimmune diseases.
Universal Cells (UCI) is announcing a Manager, Facilities Engineering opportunity at their facility in Seattle, WA .
The Manager, Facility Engineering reports to the Director, Facilities and Operations and is responsible for execution of projects to change and improve building infrastructure, utility systems, equipment, and security. The position will also be responsible for managing key GMP programs such as calibration, maintenance, and lifecycle management within a well-developed quality system for clinical and commercialized manufacturing. The position will be actively involved in facility maintenance, construction, and renovation by providing design input and oversight of equipment and engineering activities. This position must be available for weekend and after-hours support, responding to alarms and equipment alerts related to lab environment.
Universal Cells is a wholly-owned subsidiary of Astellas Pharma. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's health around the world through the provision of innovative and reliable pharmaceutical products.
Essential Job Responsibilities:
Manage and plan GMP building alteration projects in partnership with end users and stakeholders at U-Cells.
Manage outside services who execute calibration, installation, commissioning, maintenance, cleanroom disinfection, and other GxP support services.
Manage GMP assets throughout their lifecycle from defining user requirements through decommissioning. Make recommendations for preventive maintenance programs, upgrades, and repairs. Assets will include facility spaces, cleanrooms, utilities, equipment, building automation.
Develop, manage, and change facility documentation to support change controls.
Write SOP's based on solid understanding of regulatory (US, EU, JPN) requirements for the engineering function.
Use facilitative leadership and collaborative skills in a team-oriented environment to lead and engage end users in successful facility development and operational changes.
Directly manage one or more employees or contractors to accomplish functional objectives.
Education and background:
BS in Engineering and 5-7 years' experience, or
BSET in Construction or Facility Management and 5-7 years' experience, or
HS Diploma with trade or facility management certification and > 15 years relevant experience.
Provides off-hours support during emergencies/disasters and projects requiring non-business hours supervision/coordination.
Demonstrated ability to lead and manage functional teams (direct reports) as well as 3rd party service providers
Successful track record for cross-functional leadership, facilitation, project management
Construction execution / supervision / administration experience in commercial buildings
Good written and verbal communication skills and experience communicating with all organizational levels
Experience working in commercialized biopharma operation in the facilities operations and/or engineering function
Commercial operations experience in cell therapy/regenerative medicine
Advanced understanding of contamination control topics including cleanroom operation, HEPA filtration, disinfection, gowning, and proper material/personnel flow.
Experience in current requirements for lifecycle management of GMP assets
Understanding of HVAC systems for pharmaceutical facilities
Experience with building automation, monitoring systems, asset management systems, security systems
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans