Facilities Engineer

Synthego is seeking an experienced and technically driven Facilities Engineer to support the operation, maintenance, troubleshooting, and continuous improvement of critical facility infrastructure within a GMP-regulated biotech manufacturing and laboratory environment.

This role is responsible for ensuring the reliability, safety, and regulatory compliance of facility systems, with particular emphasis on GMP HVAC systems, environmental controls, hazardous materials infrastructure, and critical utilities.

The Facilities Engineer will serve as a technical subject matter expert in complex system troubleshooting, root cause investigations, nonconformance management, and engineering problem-solving. The successful candidate will demonstrate strong technical ownership, an understanding of quality management systems, and the ability to develop and implement sustainable corrective actions.

This position requires close collaboration with Manufacturing, Quality Assurance, Environmental Health & Safety (EHS), Service Engineering, and external service providers to ensure that facility infrastructure supports safe, compliant, and uninterrupted operations.

What You'll Do:

Facility Operations and Maintenance

• Support 24/7 facility operations and ensure continuity of critical systems and site security

• Oversee cleaning services, pest control, waste disposal, and other facility-related vendors

• Work alongside property management in facilitating property acquisition, maintenance events, or other services

• Maintain building operations to ensure 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 inventory of spare parts and coordinate procurement as needed

• Support and help prioritize facility improvement projects and upgrades

• Identify opportunities to improve system reliability, efficiency, and cost

• Own and report Facility KPIs and drive for improvements

• Own and improve facility procedures by drafting and revising facility SOPs and FORMs

• Maintain accurate maintenance logs, records, and documentation

GMP HVAC and Environmental Control Systems

• Provide engineering support and technical oversight for HVAC systems serving GMP manufacturing areas, controlled environments, laboratories, and hazardous materials handling areas.

• Monitor and maintain critical environmental parameters, including differential pressure, temperature, airflow, and air-change rates.

• Troubleshoot complex HVAC and building automation system issues, 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 and facility inspection readiness

• Support commissioning, qualification, requalification, and performance verification of critical facility systems.

• Implement engineering improvements to enhance system reliability, environmental control, and operational efficiency.

Root Cause Investigations and Quality Management

• Lead technical investigations involving facility equipment failures, environmental excursions, nonconformances, and other quality-related events.

• Perform structured root cause analysis using methodologies such as 5 Whys, Fishbone diagrams, fault-tree analysis, and failure mode analysis.

• Own and manage assigned nonconformance reports (NCRs), deviations, CAPAs, Change Controls, and related quality records from initiation through closure.

• Develop comprehensive technical investigation reports supported by engineering data, system trends, maintenance history, and documented evidence.

• Evaluate the effectiveness of implemented corrective actions and identify opportunities to prevent recurrence.

• Collaborate with Quality Assurance to ensure investigations, impact assessments, and documentation comply with established quality management system requirements.

• Maintain accountability for investigation timelines, quality event closure, and corrective action commitments.

Hazardous Materials and Laboratory Infrastructure

• Provide engineering support for facility infrastructure associated with hazardous chemical storage, handling, distribution, and use.

• Troubleshoot ventilation and containment deficiencies that may 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 facility system modifications and equipment installations for compatibility with hazardous materials requirements and established engineering standards.

• Collaborate with EHS to identify and mitigate facility-related hazards involving chemical storage, ventilation, hazardous waste, and emergency response systems.

• Support facility 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.

Vendor and Contractor Management

• Manage and coordinate external vendors, contractors, and technical service providers supporting facility maintenance, repairs, certifications, and engineering projects.

• Develop scopes of work, review technical proposals, and evaluate vendor recommendations.

• Provide technical oversight during system troubleshooting, preventive maintenance, repairs, and equipment modifications.

• Verify completion and quality of vendor work, 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 disruptions to manufacturing and laboratory operations.

About You:

• Bachelor's degree in Mechanical Engineering, Electrical Engineering, Facilities Engineering, or a related engineering discipline, or equivalent combination of education and relevant experience.

• Minimum 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 working in GMP-regulated biotechnology, pharmaceutical, or similarly controlled manufacturing environments.

• Strong technical knowledge of HVAC systems, environmental controls, ventilation, and building automation/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.

Additional Preferred Qualifications:

• 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.

Company Perks & Benefits

• Medical, dental, and vision benefits

• 401k Program

• Catered meals on Tuesday and Thursday

• Paid parental leave

• Flexible paid time off

• Education Reimbursement Program

Our Mission

Synthego is a pioneering force in the biotechnology industry, dedicated to advancing the frontiers of CRISPR cell and gene therapies through cutting-edge CRISPR technology and expertise. Our mission is to provide unparalleled access to best-in-class CRISPR solutions at scale, empowering agility in life science research and development from discovery through clinical trials. From streamlined approaches to licensing through full technical and regulatory support from our industry-leading experts, Synthego is enabling greater access to CRISPR technology driving to improved outcomes in patient therapeutic treatments.