Facilities Engineer II

What You'll Do

• Responsible for ensuring compliance with local, state, and federal agencies.
• Manages and completes QMS (Quality Management System) actions and items related to facility processes and equipment as needed.
• Adheres and enforces all relevant safety protocols and philosophies for internal staff members and the actions of vendors working on relevant projects.
• Works closely with other departments to define, coordinate, and execute project actions to meet established timelines.
• Owns one or more critical facilities systems, ensuring performance, compliance, and reliability across their lifecycle.
• Leads structured root cause investigations for complex or recurring equipment and system failures, driving corrective and preventive actions.
• Develops, reviews, and maintains facilities system standards, specifications, SOPs, and design documentation.
• Reviews drawings, calculations, validation documentation, and change impacts to ensure technical accuracy and regulatory compliance.
• Serves as the primary technical interface with vendors and contractors for assigned systems, including scope definition and technical decision-making.
• Leads execution of medium-scale facilities projects and system upgrades, coordinating with engineering, technicians, quality, and operations.
• Supports and leads commissioning and validation activities, including test strategy development and data analysis.
• Evaluates existing systems for process suitability, capacity, and risk; develops improvement plans as needed.
• Manages and supports change control activities through Agile PLM or equivalent systems.
• Provides technical guidance and informal mentorship to Facilities Engineers I and Facilities Technicians.
• Participates in audits and inspections as a system subject matter expert.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Carries out duties in compliance with established business policies and procedures.
• Demonstrates commitment to the development, implementation and effectiveness of applicable Quality Processes as per ISO, FDA, and other regulatory agencies.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
• Responsibility to understand and maintain awareness of the quality consequences which may occur from the improper performance of their specific job.
• Support department by performing related tasks as requested.

Required Qualifications

• Bachelor's degree (BS) in Engineering or equivalent combination of education and experience.
• 3+ years of engineering experience in a manufacturing environment.
• Working knowledge of engineering principles, methodologies, and industry standards.
• Demonstrated ability to independently troubleshoot complex equipment and system issues.
• Experience reviewing technical documentation such as drawings, specifications, calculations and change records.
• Proficient in Microsoft Suites software. (Microsoft Excel, PowerPoint, Power BI, etc.)

Preferred Qualifications

• Prior experience working in a company operating under ISO, FDA, or similar quality systems or regulations.
• Experience working in Medical Device Manufacturing or a related regulated industry.
• Strong working knowledge of HVAC systems and/or manufacturing utilities.
• Experience supporting capital projects or major systems upgrades.