Facilities Engineer

Synthego•Redwood City, CA

2d•$110,000 - $130,000

About The Position

Synthego is seeking an experienced, technically driven Facilities Engineer to support the operation, maintenance, troubleshooting, and continuous improvement of critical infrastructure in a GMP-regulated biotech manufacturing and laboratory environment. The role focuses on the reliability, safety, and regulatory compliance of facility systems, particularly GMP HVAC systems, environmental controls, hazardous materials infrastructure, and critical utilities. The Facilities Engineer serves as a technical subject matter expert in complex troubleshooting, root cause investigations, nonconformance management, and engineering problem-solving, and develops and implements sustainable corrective actions. The position works closely with Manufacturing, Quality Assurance, Environmental Health & Safety (EHS), Service Engineering, property management, vendors, and external service providers to maintain safe, compliant, and uninterrupted operations. Responsibilities span facility operations and maintenance; GMP HVAC and environmental control systems; investigations and quality management; hazardous materials and laboratory infrastructure; and vendor and contractor management.

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 conducting 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 facility vendors for cleaning services, pest control, waste disposal, and related services.
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 help prioritize facility improvement projects and upgrades; identify opportunities to improve reliability, efficiency, and cost.
Own and report Facility KPIs and drive improvements.
Draft and revise facility SOPs and forms; 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 handling areas.
Monitor and maintain environmental parameters, including differential pressure, temperature, airflow, and air-change rates.
Troubleshoot HVAC and building automation systems, including 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 involving facility equipment failures, environmental excursions, nonconformances, and other quality events.
Perform structured root cause analysis using methods such as 5 Whys, Fishbone diagrams, fault-tree analysis, and failure mode analysis.
Own and manage assigned NCRs, deviations, CAPAs, change controls, and related quality records from initiation through closure.
Prepare technical investigation reports supported by 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.
Provide engineering support for infrastructure used in hazardous chemical storage, handling, distribution, and use.
Troubleshoot ventilation and containment deficiencies that may affect employee exposure, chemical safety, or regulatory compliance.
Support critical utilities and process infrastructure, including compressed gases, specialty gas distribution, vacuum, and related monitoring and control systems.
Evaluate facility 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 safety incidents.
Manage and coordinate external vendors, contractors, and technical service providers for 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 follow site safety requirements, hazardous materials controls, and applicable GMP procedures.
Coordinate maintenance and engineering activities to minimize disruption to manufacturing and laboratory operations.