Equipment Technician

Tek Wissen

Tek Wissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. This Client is mission is to discover and deliver innovative medicines and solutions that address complex health issues and enhance people’s lives.

• Work in Biosciences Laboratories Irvine (BLI) in Irvine, CA site and is responsible for Preventive Maintenance of cGMP Utilities, Manufacturing equipment, HVAC systems, clean rooms, and the facilities, supporting GMP pharmaceutical / biotechnology operations in a safe and compliant manner; troubleshoot and respond to breakdowns, emergencies, and after-hours calls.

• Completes all required training within Maintenance department Standard Operating Procedures (SOP’s) and associated responsibilities; supports department procedures / SOP’s revisions as necessary.
• Completes Preventive Maintenance and Facilities work assignments as directed by the Maintenance Manager and Maintenance Lead.
• 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.
• Performs & documents maintenance activities such as monthly, semi-annual & annual PM’s in CMMS (Computerized Maintenance Management Systems; MAXIMO).
• Processes Purchase Orders for maintenance spare parts and service providers.
• Follows all Environmental, Health & Safety (EHS) procedures supporting efforts to improve facility EHS performance.

• GMP work experiences in Pharmaceutical/biotech operations in cleanroom environments
• Able to complete training/SOP instructions, and good documentation practices
• Hands-on experiences with equipment/utilities maintenance
• Able to use computerized system

• Experience in GMP Utilities, Manufacturing equipment, HVAC systems, pharmaceutical facility Maintenance & Calibration Programs.
• Experience with Maintenance Programs, using CMMS software (Computerized Maintenance Management Systems; MAXIMO)
• Technically competent, experience with the following systems, RODI & WFI Water systems, Clean Steam, HVAC / Clean rooms & BMS systems.
• Experience with GMP Manufacturing equipment such as fermenters / bioreactors, CIP, SIP, Autoclaves, Washers, BSC’s, Waste Inactivation is highly desired.
• Experience with computers, Microsoft Office tools (Outlook, Word, Excel); working knowledge of Data Acquisition / SCADA systems is highly desired.
• Key Stakeholders:
  Manufacturing, EHS, Engineering, QC, Validation, QA

5-7 Years

Tek Wissen® Group is an equal opportunity employer supporting workforce diversity.