Job Description
Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you!
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:
- 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. Use of fall protection/scaffolding.
Duties:
- 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 replaces HVAC filters 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
Education and Experience:
_Required_
- High School Diploma or Equivalent (GED)
_and_
- Graduation from a recognized/accredited HVAC/Refrigeration trade school or community college or equivalent programs with at least six (6) months full-time emphasis (650 hours), in air conditioning, refrigeration, electricity, and associated controls. At least two (2) years of recent full time experience as a HEPA certification technician with experience performing leak testing and velocity testing.
_or_
- Graduation from a recognized/accredited HVAC/Refrigeration trade school or community college or equivalent programs with at least six (6) months full-time emphasis (650 hours), in air conditioning, refrigeration, electricity, and associated controls. Completed a HEPA certification training program with one (1) years of experience.
_or_
- Completion of a formal Air Conditioning and Refrigeration Mechanic Apprentice Program that is approved by the United States Department of Labor or equivalent.
_or_
- Verified Military training equivalent to a recognized/accredited trade school or journeyman apprenticeship program. At least two (2) years of recent full time experience as a HEPA certification technician with experience performing leak testing and velocity testing.
_or_
- Verified Military training equivalent to a recognized/accredited trade school or journeyman HVAC apprenticeship program. Completed a HEPA certification training program with one (1) years of experience.
_or_
- No formal education. Completed a HEPA certification training program with at least five (5) years of recent full time experience as a HEPA certification technician with experience performing leak testing and velocity testing.
_Desirable_
- Demonstrate understanding of testing, adjusting, and balancing HVAC systems.
Special Skills or Abilities:
Ability to read HVAC drawings. Mechanical aptitude.
Special Job Features:
- 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. May be required to carry a pager and/or a radio.
Remarks:
Required to take immunizations as prescribed by our Company's Health Services Department.
Must wear Company issued uniform per our Company's SOP.
Position is subject to a probationary period.
Required Skills:
- Aerosol Photometers, Anemometers, Business Systems, Corrective Maintenance, Heavy Lifting, Oxygen Sensors, Prioritization, Procurement, Protective Clothing, Strategic Procurement, System Integrity
