Calibration Technician Iii
3 weeks ago
ImmunityBio, Inc. is a late-stage immunotherapy company developing a broad pipeline of next-generation therapies that drive immunogenic mechanisms for defeating cancer and infectious disease. The company’s immunotherapy platform is designed to activate both the innate (natural killer cell and macrophage) and adaptive (T cell) immune systems to create long-term “immunological memory.” The U.S. Food and Drug Administration (FDA) has accepted for review ImmunityBio’s resubmission of its Biologics License Application (BLA) for N-803, a first-in-class IL-15 superagonist, plus Bacillus Calmette-Guérin (BCG) for the treatment of BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ (CIS) with or without Ta or T1 disease, and has set a user fee goal date (PDUFA date) of April 23, 2024.
Why ImmunityBio?
- ImmunityBio is developing cutting edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.
- Opportunity to join an early-stage public biopharmaceutical company with a headquarters in Southern California.
- Work with a collaborative team with the ability to work across different areas at the company.
- Ability to join a growing company with development opportunities.
Position Summary
The Calibration Technician III is responsible for maintaining a safe work environment and conducts all responsibilities in a safe manner while following all safety Stand Operating Procedures (SOPs). The Calibration Technician III supports all equipment and utilities operations, and calibration and repair of R&D and Manufacturing equipment. The role works closely with the Validation Team to implement and execute new projects.
Essential Functions
- Performs calibration/repairs on lab equipment and cleanroom equipment
- Calibrates standards used in calibrations
- Installs new equipment; performs modifications on equipment to make it compatible with existing equipment or to enhance its functions. This may include working together with outside contractors on new installations.
- Provides advanced technical and electronic equipment repair work
- Verifies accuracy of gauges and measuring instruments such as dial indicators, fixed gauges, height gauges, and electrical and functional gauges
- Provides guidance regarding equipment operation
- Provides Measurement Data for MDT
- Manages and schedules shutdown activities from start to finish.
- Manages and schedules work for calibration and maintenance for daily operation.
- Writes investigation reports for any failed calibration specially calibration standards through Quality Management System.
- Replaces and repairs electronic and pneumatic sub-assemblies, integrated circuits, relays, and calibrate, maintain, troubleshoot, and perform repairs on the electrical and instrumentation systems; design and/or improve new or existing control systems for autoclaves, bioreactors, water systems, boilers, chillers, and HVAC systems.
- Plans and schedules Corrective Maintenance, Preventive Maintenance, and Calibration Work Orders on analytical instruments and other laboratory instruments such as pH meters, Torque tester, Refrigerators, Freezer, Incubators, water baths, conductivity meters, Mixers, etc.
- Order spare parts for critical equipment’s and materials needed for daily operations
- Performs routine calibration on instruments such as gauge, recorders, and transmitters for pressure, level, temperature, and flow.
- Prepares and maintains accurate records and reports.
- Drafts new and revises existing SOPs based on cGMP and Quality Assurance requirements.
- Supports management in audits
- Performs other projects and duties as assigned
Education & Experience
- Associate's degree (A. A.) or equivalent certification(s) from a technical school.
- Minimum of 5 years related GMP experience in the Pharmaceutical/Biotech industry required
- Experience with and working knowledge of Computerized Maintenance Management Systems (CMMS)
- Experience with and working knowledge of facilities equipment and preventive maintenance programs
- In-depth, working knowledge of Metrology and calibration programs
- GMP experience required
- Critical Utility Systems (WFI, PUW etc.). required
Knowledge, Skills, & Abilities
- Ability to speak, read, understand, and write English
- Self-starter with the ability to work with minimum supervision.
- Ability to work in a fast-paced environment and maintain a high level of customer service.
- Knowledge of and ability to use all hand tools and sets up and uses standard tools
- Knowledge of and the ability to use common laboratory measuring, calibrating, and test equipment
- Able to work independently and make sound judgments regarding work methods and tools
- Ability to read wiring diagrams, blueprints, and P&ID drawings.
- Able to understand and perform analog, digital, frequency, and time
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