Senior Facilities​/Utilities Engineer

The Principal Facilities and Utilities Engineer is responsible for designing and reviewing critical facility systems - including HVAC, water, steam, compressed air and chilled water systems and electrical infrastructure - in compliance with cGMP and regulatory standards. This role plays a pivotal role in ensuring reliable facilities operations, creating and updating preventive maintenance programs, equipment troubleshooting, and implementing solutions to minimize downtime and optimize performance.

The Principal Facilities and Utilities Engineer collaborates with cross-functional teams to support facility upgrades, energy efficiency initiatives, and capital improvement projects. Strong technical expertise, problem-solving skills, and a focus on continuous improvement are essential for success in this role.

• Knowledge and experience in:
• Oversee preventive and predictive maintenance programs (e.g SAP/CMMS) to minimize downtime and ensure compliance with cGMP, FDA, ICH, and other regulatory requirements.
• Implement innovative solutions and continuous improvement initiatives to optimize operational performance.
• Develop, update and train mechanics on Standard Operating Procedures (SOPs), work instructions, and maintenance logs for facility and utility systems.
• Manage start-up, commissioning, qualification, and validation (IQ/OQ/PQ) of facility equipment to ensure compliance with regulatory standards.
• Lead or support root cause analysis (RCA) and implement corrective/preventive actions (CAPA) for equipment failures or deviations.
• Collaborate with Engineering, Operations, Health, Safety and Environment (HSE), and Quality Assurance teams to ensure facility systems meet industry standards, regulatory compliance and production needs.
• Monitor and optimize energy efficiency, sustainability initiatives, and utility consumption to reduce operational costs.
• Oversee contractors and vendors performing maintenance, repairs, or upgrades on facility systems.
• Support capital projects, facility expansions, and equipment upgrades from design through validation and hand-over to Facilities Department.
• Ensure reliability and adherence with cGMP compliance by maintaining proper documentation, change control management, and audit readiness.
• Conduct risk assessments and implement mitigation strategies for critical utility systems.
• Maintain emergency response plans for critical utilities (e.g., backup power, water systems) to ensure business continuity.
• Participate in internal and external audits, providing necessary documentation and corrective actions as required.
• Working knowledge in SCADA/BMS.
• Familiarity in instrumentation, calibration and components for utility equipment and facilities.
• Familiar with pharmaceutical facility design such as air exchanges, differential pressures and flow directions.
• Familiarity with ASME BPE standard and ASME B31.3 and B&PV code.
• Participate in design reviews, HAZOPs, and constructability reviews to ensure quality and safety.
• Manage and resolve design changes and field issues during construction.
• Work closely with clients and stakeholders to gather requirements and present technical solutions.
• Oversees strategic planning, team coordination, and long-term reliability of systems
• Familiar with utilizing and reviewing hydraulic simulation model software e.g., Pipe Flo.
• Stay updated with industry best practices, regulatory changes, and new technologies in pharmaceutical facilities management.
• Leads larger scale projects - facility expansions, new utilities installations, etc.

Directly supervise several technical team members on the project, including training, planning, assigning, and directing work.

Proven experience in design,…