Facilities Engineer

Responsibilities

• Support operation and maintenance of facility and utility systems supporting aseptic manufacturing (e.g., HVAC, clean utilities, building infrastructure).
• Assist in monitoring system performance to ensure environmental and operational conditions meet manufacturing and regulatory requirements.
• Provide technical support for routine operations, troubleshooting, and minor system improvements.
• Ensure facilities and utilities are operated and maintained in compliance with cGMP, FDA, and global regulatory requirements.
• Support internal and external audits and inspections; provide technical documentation and SME input as needed.
• Partner with Quality and Validation to support qualification and validation activities and maintain systems in a qualified state.
• Support investigations related to deviations, alarms, and system performance issues impacting manufacturing.
• Escalate complex technical issues appropriately and support resolution efforts.
• Support preventive and corrective maintenance activities in collaboration with Maintenance and external service providers.
• Review maintenance data and trends to help identify opportunities for reliability and performance improvements.
• Support updates to SOPs, work instructions, and maintenance strategies.
• Support capital and expense projects related to facility or utility upgrades, expansions, or optimization.
• Participate in change control activities and review engineering documentation and drawings.
• Contribute to continuous improvement initiatives focused on efficiency, reliability, and compliance.
• Partner with Manufacturing, Engineering, Quality, Validation, and EHS to ensure facility systems meet production needs.
• Support risk assessments, including contamination control and environmental impact evaluations.
• Communicate effectively with internal stakeholders to align priorities and resolve issues.
• Support oversight of vendors and contractors performing facility or utility work.
• Ensure work is executed safely, compliantly, and in accordance with site procedures and expectations.

Requirements

• Bachelor's degree in mechanical engineering, Chemical Engineering, Facilities Engineering, or related technical discipline.
• 3–5 years of experience in facilities engineering, utilities, or plant engineering within a pharmaceutical, biotech, or regulated manufacturing environment.
• Experience supporting aseptic manufacturing or cleanroom environments preferred.
• Working knowledge of facility and utility systems (e.g., HVAC, building systems, clean utilities).
• Understanding of cGMP requirements, validation principles, and regulatory expectations.
• Familiarity with deviation management, change control, and CAPA processes.
• Experience using CMMS systems and supporting maintenance planning.
• Strong problem-solving and analytical skills.
• Able to work effectively in cross-functional teams.
• Clear written and verbal communication skills.
• Organized, detail-oriented, and able to manage multiple priorities.