Senior Facilities Engineer

Cordis•Irvine, CA

About The Position

Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs. The Senior Facilities Engineer leads and supports facility engineering projects with a focus on construction, infrastructure reliability, energy efficiency, and compliance with regulatory standards. This role involves managing complex engineering assignments, evaluating technical solutions, and ensuring facility systems operate effectively to support business needs.

Requirements

Bachelor’s degree in Engineering (Mechanical, Electrical, Industrial, or related discipline) and a minimum of 5 years of facilities engineering and equipment validation experience in a regulated environment.
Experience with regulated environments (FDA, cGMP, Joint Commission) strongly preferred.
Strong technical knowledge of building systems (HVAC, cleanrooms, CDA/compressed air, nitrogen generation system, power distribution, and clean utilities).
Familiarity with building codes, NFPA, NEC, ASHRAE, and OSHA regulations.
Project management experience, including budgeting, vendor management, and construction oversight.
Excellent written and verbal communication skills, with ability to interact across all organizational levels.
Proficiency with AutoCAD, CMMS, environmental monitoring systems, and building management systems (BMS).
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

Nice To Haves

Prior exposure to healthcare facilities or medical device operations is a plus.

Responsibilities

Provide engineering expertise in the design, operation, and maintenance of building systems (HVAC, ISO 8 Cleanrooms, compressed air/CDA, nitrogen generation system, electrical, plumbing, controls, and utilities).
Lead and execute equipment validation activities including IQ, OQ and requalification for manufacturing, laboratory, and facility systems.
Manage validation deviations, change controls, non-conforming material report, CAPAs, and validation-related investigations.
Lead and execute facility projects from concept through completion, including scope development, budgeting, scheduling, and contractor/vendor coordination.
Serve as subject matter expert (SME) on capital projects, renovations, and equipment installations.
Evaluate and implement improvements for building infrastructure, energy efficiency, and sustainability initiatives.
Ensure compliance with all Federal, State, local regulations, company policies/procedures including Health, Safety, Environmental, and Quality standards.
Conduct design reviews and risk assessments to ensure safe and effective startup of new processes and systems.
Troubleshoot and resolve complex engineering and facility issues with minimal supervision.
Provide technical guidance and mentorship to junior engineers, technicians, and contract staff.
Manage multiple projects simultaneously while balancing priorities and resources.
Partner with cross-functional teams (Operations, Quality, EHS, R&D, etc.) to support manufacturing and facility expansion initiatives.
Keep abreast of new technologies, codes, and best practices that may affect facility operations and capital planning.
For employees with supervisory responsibilities, ensure that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
Responsible for ensuring compliance with Quality Procedures, Laws and Regulations of the applicable markets
Performs other duties assigned as needed