Senior Maintenance Technician
NKGen Biotech is a pharmaceutical company developing natural killer (NK) cell therapies by harnessing the power of the body’s immune system. A new 23,000 sq. ft state of the art facility was constructed in Santa Ana, CA. The Facilities department is looking for maintenance technician to support technical operations at this new site. This includes facility services, maintenance, calibration and quality operation at this cGMP manufacturing plant.
- Perform facility maintenance tasks including utility equipment, DI water system, air handlers and supporting equipment, lab equipment and general facility repairs.
- Ensure clean rooms and environmental equipment are maintained to meet cGMP requirements.
- Maintain a safe work environment; work in a safe manner following all safety SOP’s and wear Personal Protective Equipment as required. Routinely perform inspections of facility safety equipment.
- Maintain accurate record keeping in compliance with cGMP requirements.
- Maintain Technical Training Profile.
- Work independently and make sound judgments regarding work methods. Proactively support the individual Departments to ensure goals and objectives are achieved.
- Assist in all facility services including physical security, janitorial, GMP cleaning, and pest control.
- Monitor and work closely with outside vendors to ensure work is completed according to specifications.
- Ensure manufacturing and all labs and lab personnel are supported to meet business needs, including: lab gasses, preventive maintenance, equipment service contracts and safety equipment.
- Ensure compliance with all applicable regulatory agencies including FDA, CA FDB, OSHA, DOH, EPA, Fire Department, city ordinance and Health Department, etc.
- Ability to work safely in an environment containing hazardous chemicals, high and low temperature liquids, high pressure liquids and gasses, steam, and mechanical systems.
- Able to work after hours and on call as needed; weekend shift support and shutdowns.
- To monitor and respond to Equipment Monitoring System alarms.
- Ensuring maintenance and calibration work orders are being completed on time while adhering to cGMP standards.
- Mechanical acumen including HVAC, purified water system, facilities utilities, P&ID’s, schematics and equipment specifications preferred.
- Experience working with Computerized Maintenance Management Systems (CMMS) required.
- Work closely with the manager to ensure strategic planning, implementations of plans or projects and resolving problems while maintaining production quality.
- Accountable to the manager and the team to meet performance metrics.
Not Required but preferred:
- Experience with Calibration principles, calibration standards, metrology methods, out of tolerance conditions and identifying non-conformance in compliance with cGMP requirements.
- An understanding of quality systems; Change Control, Deviations, CAPA’s, Audits activities.
- Experience with validation activities and technical acumen to support on going projects.
- Experience with Blue Mountain (CMMS) Computerized Maintenance Management Systems.
- The ability to work using technical metrics, identify variances & deficiencies while improving maintenance program and performance.
*The company reserves the right to add or change duties at any time.
Job Qualifications & Skills
- High School diploma, relevant trade certification, and some college or vocational training in engineering or facilities preferred.
- Must have a strong work ethic and demonstrate dependability and timeliness.
- At least 5-7 years minimum of maintenance experience in a biotech, cell therapy or pharmaceutical company with direct experience with cGMP facility operation preferred.
- Demonstrated understanding of systems including cGMP facility, HVAC, electrical, process systems, plumbing/piping, general maintenance.
- Must be able to lift, carry, push and/or pull 50 lb. of equipment or supplies.
- Must be able to squat, bend, kneel, climb, and or reach for 75% of a shift.
- Must be able to stand, walk, and/or move about for 75% of a shift.
- Good interpersonal, verbal and written communication skills are essential in this collaborative work environment.
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.