Senior Facilities Engineer

Role:  
** Sr. Facility Engineer*
* Reports to:

EHS & Facility Manager

Location:

Yorba Linda, CA

** _PURPOSE_
* * _
- The Sr. Facility Engineer is responsible for ensuring the reliability, compliance, and continuous improvement of facility infrastructure and systems supporting regulated medical device manufacturing operations. This role provides technical leadership in the planning, execution, and maintenance of facility systems including HVAC, electrical, mechanical, and critical utilities. The position ensures compliance with applicable regulatory standards (e.g., Cal/OSHA, FDA) while optimizing operational efficiency, safety, and cost-effectiveness.

The role serves as a key interface between engineering, EHS, quality, and external contractors._

** _ACCOUNTABILITIES _
* * _- describe role accountabilities/responsibilities, i.e. what the role does. Should cover the following:_

** Project Management*
* + Lead the planning, design, and execution of facility capital and expense projects including renovations, equipment installations, and infrastructure upgrades.

+ Develop and manage project scopes, schedules, budgets, and risk assessments while ensuring compliance with regulatory, safety, and internal quality standards.

+ Coordinate cross-functional stakeholders including Engineering, Quality, EHS, Production, and Leadership to align project objectives with operational needs.

+ Ensure projects meet validation, commissioning, and change control requirements within the Quality Management System (QMS).

+ Track and report project KPIs (cost, schedule adherence, performance metrics) to leadership.

** Technical Oversight*
* + Conduct engineering assessments of building systems including HVAC, compressed air, electrical distribution, plumbing, and process utilities.

+ Ensure systems meet operational requirements, uptime expectations, and environmental controls for medical device manufacturing.

+ Serve as the site subject matter expert (SME) for critical facility systems including HVAC, compressed air, vacuum systems, electrical distribution, chilled water, process gases, and plumbing systems.

+ Review and approve engineering designs, drawings, and specifications to ensure compliance with operational, safety, and regulatory requirements.

+ Ensure environmental control systems support manufacturing requirements (e.g., temperature, humidity, particulate control where applicable).

+ Support water systems including backflow prevention, wastewater neutralization, and regulatory discharge compliance.

+ Ensure calibration and monitoring systems are functioning correctly for regulated environments.

+ Monitor system performance, trends, and reliability data to proactively identify degradation or failure risks.

** Hands-On Implementation*
* + Support and participate in installation, commissioning, validation, and troubleshooting of facility systems.

+ Lead root cause investigations and corrective actions for facility-related failures or deviations impacting operations.

+ Lead or support installation, commissioning, verification, and performance qualification of facility systems and infrastructure.

+ Perform advanced troubleshooting of facility system failures, utilizing root cause analysis methodologies (e.g., 5-Why, Fishbone).

+ Develop corrective and preventive actions (CAPA) for facility-related deviations impacting production or compliance.

+ Support uptime optimization through predictive and preventative maintenance program enhancements.

** Maintenance & Asset Management*
* + Oversee facility maintenance programs using CMMS systems, ensuring completion and effectiveness of preventive and corrective work orders.

+ Develop maintenance strategies for critical assets including redundancy planning and lifecycle management.

+ Establish and track equipment reliability metrics such as MTBF (Mean Time Between Failures) and downtime trends.

+ Support spare parts management and critical inventory planning for essential systems.

** Vendor and Contractor Coordination*
* + Select, manage, and oversee contractors, engineers, and service providers to ensure quality work and compliance with site requirements.

+ Ensure contractor adherence to safety programs, site procedures, and permit requirements.

+ Source, evaluate, and manage contractors, consultants, and service providers for facility-related work.

+ Define scopes of work (SOW), review proposals, and ensure contractors meet technical and compliance requirements.

+ Enforce contractor safety programs, including LOTO, confined space, hot work permits, and site-specific requirements.

+ Conduct contractor performance reviews and ensure adherence to timelines, quality standards, and regulatory obligations.

** Documentation and Reporting*
* + Maintain engineering documentation including drawings, specifications, maintenance records, and project files in accordance with ISO 13485 and internal QMS.

+ Provide routine reporting on project status, facility performance metrics, and compliance activities.

+ Maintain and control engineering…