Facilities Planning and Compliance Specialist

2 weeks ago

Sanford, North Carolina, United States Astellas Pharma Full time
Job Overview

Facilities Planning and Compliance Specialist in BioPharma Manufacturing

Are you eager to join a diverse team dedicated to pioneering therapies for patients? At Astellas, we are committed to the advancement and delivery of innovative and effective medications for healthcare providers and patients alike. If you aspire to contribute to this impactful mission, you are welcome at Astellas.

Astellas Pharma Inc. operates in over 70 countries globally, focusing on transforming groundbreaking science into medical solutions that offer value and hope to patients and their families. Our commitment to addressing unmet medical needs while conducting our business with integrity and ethics enables us to enhance global health. For further details about Astellas, please visit our website.

About Astellas Gene Therapies

Astellas Gene Therapies is a distinguished Astellas Center of Excellence, specializing in the development of genetic treatments for patients facing rare and life-threatening conditions. With our innovative approach to genetic medicine and our leading internal manufacturing capabilities, we have established ourselves as the Astellas Center of Excellence for the newly formed Genetic Regulation Focus Area. We are actively investigating three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to broaden our focus and geographical reach within Astellas. Our operations are based in San Francisco, with manufacturing and laboratory facilities located in South San Francisco and Sanford, North Carolina.

Position Summary:

The Facilities Planner/Coordinator will play a crucial role within the Facilities Engineering department, supporting various operational areas including manufacturing, laboratories, warehouses, and administrative functions. This position will assist the facilities team in delivering high-quality services to clients and will provide opportunities for collaboration with other teams in the operation of a cutting-edge biotech facility. This role typically reports to either the Senior Supervisor of Maintenance Metrology or the Manager of Facilities and Engineering.

Key Responsibilities:
  • Develop and maintain maintenance schedules for buildings and equipment; coordinate with external contractors for equipment service and repairs; ensure compliance with maintenance records and service reports following cGMP standards.
  • Create and assign work orders using a Computerized Maintenance Management System (CMMS) and monitor their progress to ensure a balanced workload for maintenance teams.
  • Maintain master data in the CMMS for assets and equipment.
  • Address client inquiries and concerns, ensuring timely and effective resolution of issues and quality service delivery.
  • Assist in sourcing and negotiating with service vendors and suppliers by requesting, reviewing, and submitting bids and proposals, while supporting the evaluation of vendor performance.
  • Measure and report key performance indicators against service level agreements, providing facilities helpdesk services on behalf of clients and monitoring workflow for all facilities cases to ensure consistent quality of service.
  • Collaborate with internal customers, suppliers, colleagues, and support services to achieve departmental objectives.
  • Generate and adhere to standard operating procedures, supporting the site CMMS lead with system improvements.
  • Comply with all internal and external regulations and policies.
  • Work with account managers, internal customers, and vendors to meet project deadlines and provide necessary facilities project support coordination.
Quantitative Dimensions:

The Facilities Planner/Coordinator is responsible for managing master data for assets and equipment as well as maintenance schedules. They serve as a vital link in coordinating and completing service requests, agreements, and work orders, acting as a point of contact for updates.

Organizational Context:

This role typically reports to the Senior Supervisor of Maintenance Metrology or the Manager of Facilities and Engineering. The Facilities Planner/Coordinator is expected to embody our Core Values and demonstrate work performance that reflects the culture we aim to foster; operates transparently; earns trust; and supports the overall mission and vision of Astellas Gene Therapies and the Astellas organization.

Qualifications:

Required:
  • Demonstrated experience in cGMP facilities, project management, or real estate.
  • Proficient in technical writing (SOPs, maintenance procedures).
  • Experience in data entry, extensive reporting, filing, scheduling, and communication; adept at creating routine reports.
  • Strong computer skills in Microsoft Office and Facility Management systems; extensive experience with a CMMS, including planning and scheduling.
  • Excellent resource management capabilities.
  • Strong knowledge of GMP and safety practices.
  • Ability to multitask and solve problems in a fast-paced environment.
  • Exceptional communication skills, both oral and written, with the ability to effectively present information to groups.
  • Proficient in managing small projects and vendor relationships.
  • Outstanding organizational skills and attention to detail, with a proven ability to manage multiple tasks and priorities efficiently.
  • Ability to adapt to change and make sound decisions under pressure, solving problems in situations with limited standardization.
  • Commitment to maintaining high-quality standards for data integrity.
  • Collaborate closely with team members and other key stakeholders in the Astellas AGT Technical Operations team to execute tasks and may be required to perform additional duties or special projects as assigned.
Preferred:
  • Experience with BMRAM.
  • High School diploma with 6+ years of facilities coordination experience.
  • Technical certificate/license or AA degree with 4+ years of facilities coordination experience.
  • BA/BS degree with 2+ years of facilities coordination experience.
Working Conditions:
  • This role often requires extended periods of sitting, standing, and manual dexterity, including bending, stooping, and lifting up to 20 lbs.
  • This is an on-site position within a cGMP regulated manufacturing environment.
  • Occasional travel to other Astellas Gene Therapies manufacturing facilities may be required (0-5%).
Benefits:
  • Comprehensive Medical, Dental, and Vision Insurance.
  • Generous Paid Time Off policies, including vacation, sick leave, and national holidays.
  • 401(k) matching and annual company contributions.
  • Company-paid life insurance.
  • Annual Corporate Bonus and Quarterly Sales Incentives for eligible roles.
  • Long-Term Incentive Plans for qualifying positions.
  • Referral bonus program.
All qualified candidates will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or disability.

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