Instrument Technician, Operations - United States
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- 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.
- 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.
- 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.
- 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.