Director, Facilities Maintenance & Operations

UltraGenix Pharmaceutical
Bedford, MAPosted 11 March 2026

Tech Stack

Job Description

Why Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them. Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work. If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team . Position Summary: ultra innovative – Tackle rare and dynamic challenges The Director of Facilities Maintenance Operations is a leadership role responsible for strategic oversight and operational excellence of all maintenance operations functions within a highly regulated biopharmaceutical manufacturing facility and GMP QC testing lab. This role ensures the reliability, availability, and compliance of equipment, utilities, facilities, and related systems to support drug substance and drug product manufacturing in accordance with industry quality and safety standards. The Director drives continuous improvement, leads cross-functional initiatives, and serves as the site’s key technical interface during regulatory inspections and presentations. Work Model: Core Lab Ops: This role typically requires that the majority of the work be conducted on-site. Responsibilities: Strategic Leadership Management Provide vision, leadership, and strategic direction for facilities maintenance operations teams. Build and develop high-performing maintenance and calibration teams; recruit, mentor, and retain top talent. Develop departmental goals, KPIs, and performance metrics aligned with corporate objectives and operational needs. Champion reliability-centered maintenance (RCM), predictive and preventive maintenance strategies, and best-in-class maintenance engineering practices seen commonly in biopharmaceutical and highly regulated manufacturing environments. Maintenance Reliability Engineering Work with Engineering for the effective execution and continuous improvement of preventive and predictive maintenance programs to ensure optimal asset performance and minimal unplanned downtime. Support lifecycle management of critical plant and process equipment including qualification, calibration strategies, and validation support. Partner with engineering, operations, quality, and validation teams to embed risk-based maintenance planning into lifecycle activities. Regulatory Compliance Safety Ensure all maintenance and calibration activities are compliant with FDA 21 CFR Part 210/211, EU GMP Annex 1, OSHA, EPA, and other applicable regulatory, safety and environmental standards. Maintain audit-ready documentation and defend maintenance and calibration systems during regulatory inspections Lead presentations and technical discussions with regulatory bodies and support responses to audit findings, deviations, and CAPAs. Promote a culture of safety, ensuring adherence to health, safety, environmental and GMP requirements throughout maintenance work. Capital Projects Budget Management Participate in long-range facility and equipment capital ... (truncated, view full listing at source)