Facilities Engineer

Synthego•Redwood City, CA

About The Position

Synthego is seeking an experienced, technically driven Facilities Engineer to support critical facility infrastructure in a GMP-regulated biotech manufacturing and laboratory environment. The role focuses on reliability, safety, and regulatory compliance, particularly for GMP HVAC systems, environmental controls, hazardous materials infrastructure, and critical utilities. The engineer will provide technical expertise in complex troubleshooting, root cause investigations, nonconformance management, and engineering problem-solving, developing sustainable corrective actions in collaboration with Manufacturing, Quality Assurance, EHS, Service Engineering, and external service providers. The position supports 24/7 facility operations, building maintenance, vendor services, facility documentation, and improvement projects. It provides engineering oversight for HVAC and environmental control systems in manufacturing areas, controlled environments, laboratories, and hazardous materials areas, including monitoring critical parameters and supporting commissioning, qualification, audits, and inspection readiness. The Facilities Engineer leads technical quality investigations and manages assigned nonconformance reports, deviations, CAPAs, change controls, and related records through closure. The role also supports hazardous materials and laboratory infrastructure, including ventilation, containment, compressed gases, specialty gas distribution, and vacuum systems. It coordinates vendors and contractors, oversees technical work, verifies testing and documentation, and ensures work is performed in accordance with site safety and GMP requirements.

Requirements

Bachelor's degree in Mechanical Engineering, Electrical Engineering, Facilities Engineering, or a related engineering discipline, or an equivalent combination of education and relevant experience.
At least 3 years of relevant engineering experience supporting manufacturing facilities, laboratories, or critical infrastructure.
Knowledge of FDA cGMP requirements, ISO 14644, Annex 1, and applicable facility qualification practices.
Experience in GMP-regulated biotechnology, pharmaceutical, or similarly controlled manufacturing environments.
Strong technical knowledge of HVAC systems, environmental controls, ventilation, and building automation or management systems.
Demonstrated experience performing root cause investigations and implementing corrective actions.
Working knowledge of quality management systems, including NCRs, deviations, CAPAs, and change control.
Experience troubleshooting complex mechanical, electrical, controls, or utility systems.
Familiarity with hazardous materials handling environments and associated facility engineering controls.
Experience managing external vendors, contractors, and technical service providers.
Ability to interpret mechanical drawings, P&IDs, control diagrams, and engineering specifications.
Strong technical writing, analytical problem-solving, and organizational skills.
Ability to independently prioritize and execute engineering activities in a dynamic manufacturing environment.

Nice To Haves

Experience with cleanroom HVAC systems, differential pressure cascades, environmental monitoring, and contamination control.
Experience supporting chemical exhaust systems, laboratory ventilation, hazardous materials storage, and specialty gas distribution.
Familiarity with applicable Cal/OSHA requirements, California Fire Code provisions, and hazardous materials regulations.
Experience with electronic quality management platforms such as Qualio.
Familiarity with CMMS platforms, preventive maintenance programs, and equipment reliability practices.
Experience with engineering risk assessments, FMEA, and corrective-action effectiveness evaluations.
Experience supporting internal audits, regulatory inspections, and facility qualification activities.

Responsibilities

Support 24/7 facility operations and continuity of critical systems and site security.
Oversee cleaning services, pest control, waste disposal, and other facility-related vendors.
Work with property management on property acquisition, maintenance events, and other services.
Maintain building functionality, cleanliness, and organization; perform daily rounds and record readings of critical systems and equipment.
Install and relocate furniture, fixtures, and equipment in partnership with office management.
Maintain spare-parts inventory and coordinate procurement as needed.
Support and prioritize facility improvement projects and upgrades; identify opportunities to improve system reliability, efficiency, and cost.
Own and report facility KPIs and drive improvements.
Draft and revise facility SOPs and forms, and maintain accurate maintenance logs, records, and documentation.
Provide engineering support and technical oversight for HVAC systems serving GMP manufacturing areas, controlled environments, laboratories, and hazardous materials areas.
Monitor and maintain environmental parameters, including differential pressure, temperature, airflow, and air-change rates.
Troubleshoot HVAC and building automation system issues involving air handling units, exhaust systems, controls, sensors, and instrumentation.
Investigate environmental excursions, pressure cascade deficiencies, ventilation failures, and other system deviations.
Support GMP and safety audits, facility inspection readiness, and commissioning, qualification, requalification, and performance verification of critical facility systems.
Implement engineering improvements to enhance system reliability, environmental control, and operational efficiency.
Lead technical investigations into facility equipment failures, environmental excursions, nonconformances, and other quality-related events.
Conduct structured root cause analysis and manage assigned NCRs, deviations, CAPAs, change controls, and related quality records through closure.
Prepare technical investigation reports using engineering data, system trends, maintenance history, and documented evidence.
Evaluate corrective-action effectiveness and identify ways to prevent recurrence.
Collaborate with Quality Assurance to ensure investigations, impact assessments, and documentation meet quality management system requirements.
Maintain accountability for investigation timelines, quality event closure, and corrective-action commitments.
Support facility infrastructure for hazardous chemical storage, handling, distribution, and use.
Troubleshoot ventilation and containment deficiencies that could affect employee exposure, chemical safety, or regulatory compliance.
Support critical utility and process infrastructure, including compressed gases, specialty gas distribution, vacuum, and associated monitoring and control systems.
Evaluate system modifications and equipment installations for compatibility with hazardous materials requirements and engineering standards.
Collaborate with EHS to identify and mitigate facility-related hazards involving chemical storage, ventilation, hazardous waste, and emergency response systems.
Support compliance with applicable fire codes, hazardous materials requirements, occupational safety regulations, and site-specific safety procedures.
Participate in technical assessments and investigations involving hazardous materials infrastructure, ventilation failures, leaks, and other facility-related safety incidents.
Manage and coordinate vendors, contractors, and technical service providers supporting maintenance, repairs, certifications, and engineering projects.
Develop scopes of work, review technical proposals, and evaluate vendor recommendations.
Provide technical oversight during troubleshooting, preventive maintenance, repairs, and equipment modifications.
Verify vendor work quality and completion, including required testing, commissioning, and documentation.
Ensure contractors comply with site safety requirements, hazardous materials controls, and applicable GMP procedures.
Coordinate maintenance and engineering activities to minimize disruption to manufacturing and laboratory operations.