- This position provides system-wide support in the testing and certification of critical ventilation used in pharmacy sterile compounding, hazardous drug preparation, laboratory applications, biosafety containment facilities, and protected environments.
- This position coordinates specialized environmental monitoring in sterile compounding and hazardous drug preparation and administration areas and manages the certification and testing vendor contract to ensure adherence to contract quality standards and financial constraints.
- This position supports the system occupational safety and health program and ensures worker safety and patient safety.
- Ventilation Testing and Certification: Coordinates, plans, and executes critical environment testing and certification including local exhaust ventilation, isolation rooms, operating rooms, biological safety cabinets, chemical fume hoods, pharmacy compounding aseptic isolators, pharmacy compounding aseptic containment isolators, laminar flow hoods, clean room suites, biosafety containment facilities, and other ventilation controls. Manages test equipment maintenance and calibration. Maintains inventory and testing schedule of all critical ventilation.
Chair and ensure Quality reporting for Institutional USP 800 committee.
Manage the contract for the company that provides viable bacterial and fungal air samples and surface samples in sterile compounding facilities.
- Manage the collection of hazardous drug surface samples and other industrial hygiene and environmental samples. Manages sampling supply inventories.
- Liaison to HVAC and Engineering at both Longwood campus and satellite locations.
- Technical Reports: Prepare technical reports and tests report documentation. Interprets and analyzes laboratory test results, interprets regulatory requirements, formulates findings, and recommends corrective measures to pharmacy management, laboratory management, safety mangers, and facilities engineering.
- Plan Review: Provide technical plan review for specialized ventilation systems, contamination control, and sterile compounding facility design.
- Exposure Assessment and Control: Exposure assessments and indoor air quality studies as needed.
- Maintain procedural knowledge to properly evaluate laboratory ventilation devices and work cooperatively with other EHS professionals to evaluate the performance chemical exhaust hoods annually (smoke tests and face velocity tests) in accordance with current ANSI/AIHA Z9.5 standards. Ensure that all new hood installations comply with current industrial standards including ASHRAE 110 as installed testing. Help maintain a database of ventilation devices to track test results, service requests, and provide documentation to management on repair status. Interact with Facilities Management HVAC and Controls staff to correct ventilation issues. Assist in other aspects of laboratory ventilation and design. Provide technical guidance to Facility Engineers and contractors regarding building design and HVAC systems relevant to laboratory ventilation systems. Other responsibilities: Assists with the evolution and implementation of DFCI’s industrial hygiene program. Travels to DFCI facilities to perform assigned duties. Acts as a contamination control subject matter expert and resource for others by communicating appropriately with stakeholders and facility personnel.
- Bachelor's degree in industrial hygiene, engineering, environmental health, public health, occupational health, chemistry, biology, microbiology, physics, or other technical field. Six years of industrial hygiene or critical environment testing experience may be substituted for educational requirement
- Demonstrated knowledge of USP, USP, and CETA CAG-003 testing and certification requirements.
- Demonstrated knowledge of NSF 49, ASHRAE 170, and other ventilation standards.Valid driver's license and meet routine driver qualifications.
- Ability to develop checklists for sterile compounding facility preventive HVAC preventive maintenance (shut-down and return to service).
- Ability to evaluate primary and secondary engineering controls for their ability to protect staff and the sterility of the work product
- Demonstrated ability to read and understand mechanical drawings and architectural drawings.
- Experience testing and certifying sterile compounding cleanrooms, primary engineering controls, compounding aseptic containment isolators, compounding aseptic isolators, biological safety cabinets, chemical fume hoods, high containment facilities, protective environment rooms, or other engineering controls.
- Experience writing technical reports and test reports.
- Demonstrated basic knowledge of OSHA, EPA, and applicable Joint Commission standards and regulations.Experience using word processing, spreadsheet, database, internet, e-mail, and scheduling applications.
- Experience in a role requiring effective verbal, written, and interpersonal communication skills
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