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Instrument Technician, Operations Santa Monica United States,  

Job Score (company)


Posted on : 01 June 2017

Project Description

Description:
  • Our company  is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. 
  • The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. 
  • We are seeking an Instrument Technician, Operations to oversee an 18,000 square foot clinical biotechnology facility that includes general laboratories for bio-processing.  
  • In addition to facilities oversight activities, the Maintenance Instrument Technician, Operations will assist in the operation and maintenance of the company s facility for production of cell-based therapeutics.
  


Responsibilities include but are not limited to:
  • Maintain a safe work environment; work in a safe manner following all safety SOP s and wear Personal Protective Equipment as required. 
  • Maintain accurate records keeping equipment and systems cGMP compliant at all times. 
  • Responsible for general day to day checks of equipment 
  • Response and document equipment alarms following applicable company SOP s. 
  • Supervise calibration activities. 
  • Support drafting and maintaining department SOP s. 
  • Manage and track deviations within the Facilities department. 
  • Initiate change control as related to investigations, procedural changes, and other system/equipment upgrades. 
  • Complete calibrations and PMs with accurate and timely GMP documentation following company SOP 
  • General repair and maintenance jobs around the buildings. This will include both mechanical and electrical issues. 
  • Work independently and make sound judgments regarding work methods and tools. Proactively support the Corporations, Companies, Departments and Personal goals and objectives. 
  • Coordinates assigned activities with outside contractors and vendors. Assist in the selection and monitor the performance of outside contractors and vendors. 
  • Ensure manufacturing and all labs and lab personnel are supported to meet business needs, including:  site gas changes, preventive maintenance, equipment calibrations, equipment service contracts and safety equipment 
  • Ensure compliance with all applicable regulatory agencies including FDA, CA FDB, OSHA, DOH, EPA, Fire Department, city audits, Health Department, etc. 
  • Maintain your Technical Training Profile current with no delinquent notices. 
  • Ability to work safely in an environment containing hazardous chemicals, high and low temperature liquids, high pressure liquids and gasses and moving machinery. 
  • Able to work after hours and on call as needed;  weekend shift support, swing shift and shutdowns 
  • Other duties may be assigned. 



Requirements:
  • High School diploma, relevant trade certification, and some college or vocational training in engineering / instrumentation controls. 
  • Experience using Rockwell based Critical Equipment Management System (CEMS) is required. 
  • Ability to troubleshoot electrical, controls, gas systems and CEMS monitoring equipment. 
  • Must be able to read and understand technical drawings and schematics. 
  • Must have a strong work ethic and demonstrate dependability and timeliness. 
  • At least 5 years of maintenance experience in a biotech or pharmaceutical company with direct experience with GMP facility operation preferred. 
  • Exposure to operations involving engineering disciplines including Electrical, Mechanical, Civil, Structural, Environmental, and Industrial. 
  • Demonstrated understanding of systems needed to manage a GMP facility such as:  electrical, quality, process systems, calibration, and 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 50% 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. 
 


About Us:
  • Our company is an equal opportunity employer.
  • We are able to offer the opportunity to be part this successful, fast growing company.  A place everyone knows your name and respects your opinion while at the same time offering benefits and time off packages commensurate to any large corporation.   

Locations

Santa Monica CA

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