The Senior Critical Environment Instrumentation Supervisor is a leadership role responsible for managing instrumentation systems, teams, and compliance initiatives within biosafety laboratories. This role ensures the integrity, accuracy, and regulatory adherence of systems monitoring environmental conditions, including containment pressures, airflow, temperature, humidity, and gas detection.
As a senior supervisor, this individual develops SOPs, leads investigations, supports audits, manages vendor performance, and contributes to long-term instrumentation strategy and capital improvement planning.
Oversee the daily operations of all instrumentation and environmental control systems in BSL-2/3/4 labs, ensuring accuracy and reliability.
Manage a team of technicians and junior supervisors across multiple lab zones and shifts.
Lead planning and execution of calibration, maintenance, and system validations for:
Differential pressure systems
Biosafety cabinet (BSC) airflow and filter monitors
Room pressurization sensors and interlocks
Toxic/flammable gas detection systems
HVAC-linked temperature and humidity instrumentation
Develop and implement SOPs for environmental instrumentation and related emergency protocols.
Ensure compliance with regulatory bodies such as CDC, NIH, WHO, FDA, and local biosafety guidelines.
Manage instrumentation data integrity and documentation within BMS, SCADA, EMS, and CMMS systems.
Lead root cause analyses and CAPA activities related to instrumentation or containment breaches.
Provide input on capital planning, procurement of new sensors and systems, and instrumentation upgrades.
Serve as the subject matter expert (SME) during internal/external audits and biosafety inspections.
Regulatory Compliance Leadership
Ensure all systems supporting biosafety containment meet or exceed CDC/NIH/WHO standards.
Maintain 100% audit-readiness for calibration and instrumentation records.
Instrumentation Oversight & Optimization
Manage complex instrumentation networks tied to airflow control, HEPA filtration, pressure zoning, and decontamination cycles.
Optimize integration of digital instrumentation with BMS/SCADA systems.
Technical Leadership & Escalation Support
Act as the escalation point for instrumentation failures, system alarms, or deviations.
Review and approve technical reports, investigations, and corrective actions.
Team Development & Resource Management
Mentor and train junior technicians and supervisors.
Oversee workforce allocation and performance reviews for instrumentation staff.
Strategic Planning & Asset Lifecycle Management
Drive improvement initiatives, sensor standardization, and instrumentation lifecycle planning.
Participate in capital projects and advise on instrumentation scope, specifications, and vendor selection.
Data Integrity & Digital Integration
Ensure compliance with 21 CFR Part 11, ALCOA+ principles, and cybersecurity standards for instrumentation platforms.
Validate data logging, remote monitoring, and alert systems tied to critical sensors.
Education:
Bachelor’s or Master’s degree in Instrumentation, Electronics, Mechatronics, Biomedical, or related engineering field.
Experience:
8+ years of hands-on instrumentation experience, including 4+ years in a supervisory role within BSL-2/3/4 or GMP-controlled environments.
Certifications (Preferred):
BSL-3/4 Facility Training
ISO 17025 / GMP Compliance
OSHA 30 / CDC Biosafety Certification
CMMS/BMS/SCADA System Administration Certification
Advanced knowledge of:
Critical containment instrumentation
BMS/SCADA/EMS platforms (Honeywell, Siemens, Delta, etc.)
Sensor calibration techniques & data analytics
Root cause analysis tools (e.g., 5 Whys, Fishbone, FMEA)