Job Application for Director, Facilities Maintenance & Operations at Ultragenyx Pharmaceutical

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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:

ultrainnovative – 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 planning; identify necessary capital projects, upgrades, and equipment installations for facilities and utilities.
Prepare and manage departmental operating and capital budgets; optimize cost, quality, and service delivery.
Collaborate with cross-functional teams (manufacturing, quality, project management, validation) to align maintenance engineering projects with business and compliance goals.

Cross-Functional Collaboration & Communication

Act as the primary maintenance operations representative to site leadership and stakeholders.
Provide regular reports to senior leadership on reliability, maintenance performance, risks, and improvement initiatives.
Cultivate partnerships with external vendors, original equipment manufacturers, and service providers to maintain high levels of technical expertise and service

Knowledge & Competencies

Comprehensive knowledge of 21 CFR Part 210/211, EU GMP Annex 1, OSHA, and relevant environmental regulations.
Strong analytical, problem-solving, and decision-making skills with a reliability engineering mindset.
Excellent communication skills with the ability to influence at all organizational levels.
Experience with budget oversight, project prioritization, risk management, and cross-functional leadership.
Proficient in industry best practices including Lean, Six Sigma, and risk-based equipment management.

Requirements:

Bachelor of Science (B.S.) degree in Mechanical Engineering, Electrical Engineering, or a closely related engineering discipline
15+ years of progressive experience in maintenance engineering or reliability functions within biopharmaceutical, pharmaceutical, or other highly regulated manufacturing environments.
Leadership experience with roles in engineering and maintenance teams and functions.
Demonstrated experience presenting to, and interacting with, regulatory agencies (FDA, EMA or equivalent).
Deep familiarity with GMP compliance, clean utilities (e.g., HVAC, WFI, compressed gases), cleanrooms, sterile manufacturing processes, critical manufacturing equipment, and facility infrastructure.
Proven track record in implementing maintenance management systems (CMMS), reliability strategies, and continuous improvement initiatives
Experience supporting deviation investigations, root cause analysis, and CAPA implementation
Ability to read and interpret technical drawings, equipment manuals, and engineering specifications
Strong organizational skills and attention to detail in a fast-paced, compliance-driven environment

Physical Demands/Work Environment/Safety Considerations:

Stand for extended periods of time wih periodic stooping / bending / kneeling.
Ability to climb ladders and stairs of various heights.
Able to lift, push, pull up to 50lbs.
Work in a controlled environment requiring GxP gowning and wear protective clothing over the head, face, hands, feet, and body. This requires the ability to change clothes into appropriate gowning and personal protective equipment.
Certain tasks may require use of a respirator; medical clearance will be required in advance.
Must remove all make-up, jewelry, and contract lenses while in the manufacturing environment.
Working in termperature-controled environments (cold rooms).

#LI-CS1 #LI-Onsite

The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicant's geographic location.

This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.

Pay Range

$1 - $2 USD

Full Time employees across the globe enjoy a range of benefits, including, but not limited to:

· Generous vacation time and public holidays observed by the company

· Volunteer days

· Long term incentive and Employee stock purchase plans or equivalent offerings

· Employee wellbeing benefits

· Fitness reimbursement

· Tuition sponsoring

· Professional development plans

* Benefits vary by region and country

Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at talentacquisition@ultragenyx.com.

See our CCPA Employee and Applicant Privacy Notice.

See our Privacy Policy.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to: talentacquisition@ultragenyx.com.

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Director, Facilities Maintenance & Operations

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