- Under the supervision of the Maintenance and Utilities Supervisor and direction of the maintenance team leader, installs, maintains, tests/certifies, repairs and troubleshoots HEPA filtration equipment
- In compliance with operating procedures, Company and Government regulations, and current Good Manufacturing Procedures, assures the quality of our products and services are of the highest priority
- HEPA Technicians will perform maintenance on any equipment or facilities which their skills support in a compliant quality manner
- HEPA Technicians will work in classified facilities which will require aseptic gowning, satisfactory titers, and RODAC testing
- HEPA Technicians are part of the General Technician work group and will primarily share work assignments within their job grouping with no inherent or “system imposed” limits
- Based on business needs, General Technicians will perform maintenance activities including crossing between job groupings where skills are common
- Work assignments, building and equipment are not exclusive to any craft, job grouping, or employee
- Position may include some responsibility for maintaining significant business systems (e.g., EAM data, planning, procurement, and scheduling) including the authority to assign, coordinate, and maintain work for others
- EQUIPMENT: Including but not limited to
Aerosol Generator (Laskin nozzle or Thermal), Aerosol Photometer with scanning wand and probe, Anemometer (Rotary Vane or Hot Wire), Balometer/Multimeter w/VELGrid or Flow Hood, Forward Light Scatter Particle Analyzer with isokinetic sample probe (Discrete Particle Counter or DPC), Tecnol Fluid Shield respirator, Oxygen sensor
- Electronic data collection technology (i.e. automation/robotics)
- Portable and fixed power and hand tools, adhesives/sealants, ladders, chemical cleaning equipment, protective clothing and safety devices, electronic/electric measuring devices, two-way radios
- 1st Shift: Tuesday - Saturday 7:30 am to 4:00 pm
- 2nd Shift: Tuesday to Saturday 3:30 pm to 12:00 am
- Perform and document HEPA Certifications of Unidirectional Airflow Rooms and Hoods (UARH), Class I/ Class II Biosafety Cabinets (BSC), Air Handler Units (AHU), HEPA Filtered Miscellaneous Equipment (ME)
- Perform leak checks, velocity spot checks, non-viable particle counts, airflow pattern tests, and/or other tests per procedure
- Routinely involves working from ladders and working above head height for 6 or greater hours per day
- Verifies equipment number and work order association prior to conducting HEPA certification related tasks
- Affix certification tag or Equipment Defective Notice tag on equipment per procedure
- Manages and maintains all equipment necessary to support HEPA certifications and velocity spot checks
- Performs EAM transactions as necessary
- Use of electronic data collection technology
Performs corrective maintenance to repair, replace, and/or make adjustments to equipment, proactively or following, certification failure e.g. filter structural repairs and HEPA filter replacements
- Assists Utilities technicians to troubleshoot and adjust HVAC systems to maintain proper airflow conditions
- Monitors and measures pressure drop of HVAC filters and replaces them as necessary, observing all system integrity and safety requirements
- Carries radio as directed for expeditious communication of problems
- Works from work orders and PM checklists and maintains necessary work records and logs in a cGMP compliant manner, documenting activities via daily labor records and other GMP systems as necessary
- Communicates effectively in a professional manner with supervision and customers to provide equipment and system status, parts and other work requirements
- Completes department training requirements, e.g. orientation, SOP, safety, etc. as directed from supervision
- Attend and actively participates in HAZOPS, waste walkthroughs, Kaizen events, or any other operations, lean six-sigma, quality, safety or environmental training/initiatives as required
- Prepares and assists technicians, supervisors and planners in preparing labor and material estimates
- Assists supervision with the assigning, scheduling and prioritization of work order request using maintenance management systems
- Makes recommendations and prepares orders for spare parts, additional stock room items, tools, etc
- Consults with Supervision and other mechanics on problem resolution/troubleshooting
- Keeps Supervision informed of problem issues
- Write, execute, and complete safety permits
Heavy lifting, aseptic gowning, heat and cold, dust and dirt, subject to immunization, safety shoes and glasses, subject to emergency call-in, working in confined spaces and roofs and at heights, possible work in areas of potentially infectious agents and available at all times during work shift to answer emergencies
- Required to take immunizations as prescribed by our company Health Services Department
This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely
