Facilities/Engineering Compliance Supervisor

Job Description

Job Description

Reporting to the Sr. Facilities Manager, this onsite role owns the work order system, manages facility drawings, coordinates engineering and maintenance schedules, and authors deviations, CAPAs, and change controls from creation through closure. The Supervisor serves as the Quality Systems owner for the Facilities and Engineering function and partners cross-functionally with Production, Laboratory, and Quality on investigations and corrective actions.

Principal Duties

• Coordinate Facilities and Engineering schedules across engineering projects, preventive maintenance, calibration activities, and plant shutdowns.
• Own the CAPA, deviation, and change control processes from creation to closure, including investigation, root cause analysis, and effectiveness verification.
• Author technical documentation including deviation investigations, CAPAs, SOPs, protocols, and reports in compliance with cGDP requirements.
• Serve as the Quality Systems owner for the Facilities and Engineering function, ensuring documentation, records, and processes meet FDA regulatory expectations.
• Own and administer the CMMS (Computerized Maintenance Management System), including work order planning, scheduling, execution monitoring, and reporting.
• Manage facility drawings, including maintenance and editing using CAD software.
• Support validation executions, including temperature mapping of TCUs (Temperature Control Units), as needed.
• Accurately perform and record readings of various equipment across the site.
• Manage external vendors and contractors for preventive maintenance scheduling, on-site coordination, and work completion verification.
• Prepare and present maintenance, validation, and calibration reports for monthly and quarterly business reviews.
• Partner cross-functionally with Production, Laboratory, Quality, and other departments on investigations and any cross-functional CAPA activities.
• Perform other duties as assigned.

Qualifications and Experience

Required:

• 5+ years of experience in maintenance planning and/or technical writing within an FDA-regulated manufacturing environment.
• Thorough working knowledge of CAPA, deviation, and change control processes from creation to closure, including investigation and root cause methodology.
• Demonstrated technical writing proficiency across deviations, CAPAs, SOPs, and validation documentation.
• Working knowledge of cGDPs (current Good Documentation Practices).
• Hands-on experience administering a CMMS, including work order planning, scheduling, and monitoring.
• Proficiency with CAD software for facility drawing maintenance and editing.
• Experience supporting validation activities, including temperature mapping of TCUs.
• Demonstrated ability to manage vendors and contractors for PM-related work.
• Strong written and verbal communication skills, including the ability to present technical reports to leadership.
• Ability to work onsite full-time in Costa Mesa, CA.