Astellas Pharma Manager, Facility Engineering in Seattle, Washington

Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.

There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.

Astellas is announcing a Manager, Facility Engineering opportunity at their Universal Cells facility in Seattle, WA.

Purpose:

The Manager, Facilities Engineer reports to the Director, Process Development and is responsible for the oversight and support of critical equipment and systems in the facility. The individual will take ownership of maintaining equipment, coordinating and approving equipment service, and resolving facility issues. The engineer will be actively involved in facility design, construction, and renovation by providing design input and oversight of construction activities.

Essential Job Responsibilities:

  • Maintain, support, and update a real-time equipment monitoring system.
  • Install, test, calibrate, and qualify equipment.
  • Write SOPs for equipment installation, maintenance, and use.
  • Author investigation and excursion reports as well as process CAPAs and Deviations.
  • Support EH&S policies and their implementation.
  • Primary interface with building owners for all facility related issues. Where possible directly responsible for maintenance and repair of HVAC, HEPA filters, etc.
  • Primary responder for facility and equipment alarms or issues. Implementing emergency measures as appropriate for area impacted.
  • Oversight of facility design and construction processes from functional design through qualification and routine use.
  • Monitor and replace gas tanks supporting critical processes and materials.

Qualifications:

Required

  • Minimum of 5+ years of Facility Engineering experience.
  • Bachelor's degree in engineering or scientific discipline.
  • Working knowledge of and experience with FDA, ICH, and PMDA facility expectations for aseptic processing.
  • Excellent organizational and time management skills with the ability to balance projects by priority.
  • Strong problem solving and analytical skills to identify and implement technical solutions.
  • Ability to work independently.
  • Excellent communication skills.
  • Experience managing third party contractors.
  • Experience calibrating and maintaining laboratory equipment.
  • Experience with real-time monitoring systems.
  • Experience following Good Documentation Practices (GDP).

Preferred

  • Automated system design, engineering, and implementation experience.
  • Experience with IQ/OQ/PQ in GMP environment.
  • Experience with asset tracking software.
  • Leadership experience.

Disclaimer

The statements above are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time.

*LI-JA

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

Category Facilities