The Senior Facilities Engineer is responsible for the design, operation, maintenance, and continuous improvement of facility infrastructure and critical utility systems supporting manufacturing. This role ensures compliance with GMP, FDA, and safety regulations while maintaining high levels of reliability and efficiency across all facility operations.

Key Responsibilities

• Oversee operation and maintenance of critical utilities, including HVAC, WFI systems, clean steam, compressed air, chilled water, and electrical systems.

• Ensure facility systems comply with GMP, FDA, and regulatory standards.

• Lead preventive and predictive maintenance programs to maximize equipment reliability and uptime.

• Support and manage capital projects, including equipment upgrades, facility expansions, and system installations.

• Collaborate with manufacturing, quality, validation, and maintenance teams to ensure uninterrupted production.

• Drive continuous improvement initiatives focused on energy efficiency, reliability, and cost reduction.

• Provide technical leadership in troubleshooting and root cause analysis of facility-related issues.

• Support equipment qualification (IQ/OQ/PQ) and validation activities for facility systems.

• Maintain documentation, SOPs, and engineering standards aligned with compliance requirements.

• Manage contractors, vendors, and service providers to ensure quality and timely execution of work.

• Ensure compliance with EHS (Environmental, Health & Safety) standards and promote a safe working environment.

• Project Management

Qualifications

• Bachelor’s degree in Mechanical, Electrical, or related field.

• 5+ years of experience in facilities engineering, preferably in pharmaceutical or regulated manufacturing.

• Strong knowledge of GMP, FDA regulations, and validation processes.

• Experience with critical systems such as cleanrooms, HVAC, WFI, and utilities.

• Proven experience in project management and cross-functional collaboration.

• Strong problem-solving, leadership, and communication skills.

Preferred Qualifications

• Experience in medical device or pharmaceutical manufacturing environments.

• Knowledge of CMMS systems and maintenance planning.

• Certification in project management or facilities engineering (e.g., PMP, CFM) is a plus.