Ultragenyx Pharmaceutical

Supervisor, GMP Facilities

Bedford, MA · Staff+ · Full-time

No sponsorship$107k-$133kDetected 21 days ago

ComplianceExcelHRGMPFDA RegulatoryMedical DevicesLeadershipCommunicationCollaborationProblem SolvingOrganizational SkillsMicrosoft OfficeGxP

About the role

ultra focused - Work together to fearlessly uncover new possibilities
This role is for a highly skilled and detail-oriented Facilities Supervisor responsible for overseeing maintenance operations in a regulated Good Manufacturing Practice (GMP) environment.
Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site.

Plan, schedule, and manage preventive and corrective maintenance schedules for GMP-critical equipment and systems to minimize downtime and ensure operational continuity
Maintain accurate and timely documentation of maintenance activities in the Computerized Maintenance Management System (CMMS)
Lead troubleshooting efforts and conduct root cause analysis for equipment failures, implementing corrective actions
Collaborate with Quality Assurance, Manufacturing, and Engineering teams to ensure equipment and facility readiness for production and audits
Participate in audits and inspections conducted by internal teams and regulatory agencies, providing necessary documentation and support
Support deviation investigations and CAPA management by providing technical input, maintenance history, and contributing to timely resolution and documentation
2+ years of supervisory or team lead experience in a maintenance or facilities role

Strong knowledge of GMP, FDA, EMA, and other applicable regulatory requirements and industry standards
Demonstrated experience in planning, scheduling, and executing preventive and corrective maintenance programs
Familiarity with HVAC, clean utilities (e.g., WFI, clean steam, compressed air), and critical manufacturing equipment
Experience supporting deviation investigations, root cause analysis, and CAPA implementation
Ability to read and interpret technical drawings, equipment manuals, and engineering specifications
Ability to climb ladders and stairs of various heights.
This requires the ability to change clothes into appropriate gowning and personal protective equipment.

$107,300 - $132,500 USD
Volunteer days
Long term incentive and Employee stock purchase plans or equivalent offerings
Professional development plans
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.

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 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.
Associate or bachelor's degree in engineering, Facilities Management, or a related field (or equivalent combination of education and experience)
6+ years of maintenance experience in a GMP-regulated pharmaceutical, biotechnology, or medical device environment

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.

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.

This listing is sourced directly from Ultragenyx Pharmaceutical's careers page and normalized into a canonical job model.