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
