Company

Nkgen BiotechSee more

addressAddressSanta Ana, CA
type Form of workFull-Time
CategorySales/marketing

Job description

Job Description

Facilities, Building and Equipment Technician III

Job Summary

The Facilities, Building and Equipment Technician III is responsible for Preventive Maintenance of the Facility, cGMP Utilities, Manufacturing/analytical/supporting equipment, HVAC systems, clean rooms/labs, and the facilities/building, supporting GMP pharmaceutical / biotechnology operations in a safe and compliant manner; troubleshoot and respond to breakdowns, emergencies, and after-hours calls.

General Responsibilities

  • Performs Preventive Maintenance on a wide variety of cGMP Utilities & Manufacturing equipment, HVAC and the facility within Good Manufacturing Practices (GMP), safety and other applicable regulations.
  • Plan / schedule / manage vendors as needed for scheduled and unscheduled work. Monitor vendor work, ensuring quality and compliance. Review all vendor work and documentation for accuracy and completeness.
  • Coordinates, performs & documents maintenance activities such as monthly, semi-annual & annual PM’s in CMMS (Computerized Maintenance Management Systems; Blue Mountain).
  • Processes Purchase Order Requests for maintenance spare parts, tools, and service providers.
  • Supports investigations for facility & utilities non-conformances and their impact on manufacturing, processes, and Equipment systems.
  • Completes all required training within Facilities department Standard Operating Procedures (SOP’s) and associated responsibilities; revises department procedures / SOP’s as necessary and as directed by the Facilities Manager.
  • Supports internal / external audits for Facilities department, coordinate observations responses accordingly.
  • Follows all Environmental, Health & Safety (EHS) procedures supporting efforts to improve facility EHS performance.
  • Respond to requests for building re-organization, general office/facility issues (such as lighting/doors/sinks/toilets and grounds)
  • Maintain a clean and organized work/office area/tools/supplies/storage.
  • Monitor and respond to Building Monitoring System (BMS) alerts and alarms.
  • Performs other related duties as assigned.

Job Qualifications & Skills

  • Associate or technical degree / High School diploma with minimum 7 years of related experience in GMP pharmaceutical manufacturing environment, preferred experience in predictive maintenance, mechanical / electromechanical fields.
  • Experience in GMP Utilities, Manufacturing equipment, HVAC systems, pharmaceutical facility Maintenance & Calibration Programs.
  • Experience with Maintenance Programs, using CMMS software (Computerized Maintenance Management Systems; Blue Mountain)
  • Working knowledge of Change Control management; non-conformance investigations, CAPA’s, Risk Assessments and Action items.
  • Technically competent, experience with the following systems, Liquid Nitrogen and CO2 distribution, HVAC / Clean rooms & BMS systems. Experience with GMP Manufacturing equipment such as freezers, refrigerators, incubators, centrifuges, BSC’s.
  • Experience with computers, Microsoft Office tools (Outlook, Word, Excel); working knowledge of Data Acquisition / SCADA systems is highly desired.
  • Team player with strong customer orientation, ability to work independently in cross-functional & multicultural environment.
  • Good Communications skills and Technical report writing skills.
  • Experience with clean rooms and gowning procedures for ISO5/ISO7

Benefits & Perks

  • Competitive compensation
  • Medical, Dental and Vision Insurance
  • Business casual work attire
  • Fully stocked kitchen and much more!

Compensation

  • $80,000- $85,000 per year
  • Hourly Position
Refer code: 8627535. Nkgen Biotech - The previous day - 2024-03-18 17:08

Nkgen Biotech

Santa Ana, CA
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