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Facilities/Engineering Compliance Supervisor
Job in
Costa Mesa, Orange County, California, 92626, USA
Listed on 2026-06-01
Listing for:
Pyramid Pharma Services, Inc.
Full Time
position Listed on 2026-06-01
Job specializations:
-
Engineering
Quality Engineering
Job Description & How to Apply Below
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.
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.
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