Specialist, Facilities Planner and Compliance
Astellas

Job Info

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Specialist BioPharma Manufacturing Facilities Planner and Compliance

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.

About Astellas Gene Therapies

Astellas Gene Therapies is an Astellas Center of Excellence developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for their newly created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina. For more information, please visit our website: www.astellasgenetherapies.com.

The Role:

The Facilities Planner/Coordinator will be part of the Facilities & Engineering department supporting the Manufacturing, lab, warehouse, and administrative areas. This position will assist the facilities team in delivering quality services to clients and the opportunity to collaborate with other teams in the operation of a state-of-the-art biotech facility. This role typically reports to either the Senior Supervisor, Maintenance & Metrology OR Manager, Facilities and Engineering.

Responsibilities:

• Create and maintain building and equipment maintenance schedules; coordinate with outside contractors for the service and repairs of equipment; confirm maintenance records and service reports following cGMP.
• Generate and assign work orders using a CMMS and monitor Work Order progress to ensure a balanced workload for maintenance crews.
• Create and maintain master data in the CMMS for assets/equipment.
• Address client inquiries and concerns ensuring timely, quality issue resolution, and service delivery.
• Assist in sourcing and negotiating with service vendors and suppliers through requesting, reviewing, and submitting bids and proposals and support the monitoring and assessment of vendor performance.
• Help with measuring and reporting key performance indicators against service level agreements. Provide facilities helpdesk services on behalf of the client(s) and monitor internal/external workflow for all facilities cases to ensure consistent quality of service and work product.
• Partner with internal customers and suppliers, colleagues, and support services to achieve department goals.
• Generate and follow standard operating procedures. Support the site CMMS lead with issues and system improvements.
• Understand and adhere to all internal and external regulations & policies.
• Collaborate with account managers, internal customers, and vendors to meet deadlines and provide facilities project support & coordination as necessary.

Quantitative Dimensions:

The Facilities Planner/Coordinator is responsible for the master data for assets and equipment and the maintenance schedules. They are a vital link to the coordination and completion of service requests, agreements, and work orders. This position will support all facets of the various requests and a point of contact for updates.

Organizational Context:

The Facilities Planner/Coordinator will typically report to the Senior Supervisor, Maintenance & Metrology OR Manager, Facilities and Engineering. This role is expected to model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas Gene Therapies and the Astellas organization.

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