Instrumentation Team Lead

Employer
Kite Pharma
Location
Frederick, MD, United States
Posted
Aug 12, 2019
Ref
R0009240
Required Education
Masters Degree/MBA
Position Type
Full time
Everyone at Kite is grounded by one common goal - curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!

We are seeking a highly motivated Instrumentation Team Lead to oversee our new manufacturing and administration buildings in Frederick, Maryland which includes general laboratories for bio-processing and manufacturing. In addition to facilities oversight activities, you 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:
  • Supervises Instrumentation & Calibration Technicians, including organizing and prioritizing daily tasks, performing training, repair, calibration of instrumentation and equipment, ensuring that Standard Operating Procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements are followed.
  • Install, calibrate, fix, repair, and modify process control instruments or systems for manufacturing applications as well as electronic, electromechanical, and pneumatic control devices for utility systems which support the manufacturing facilities.
  • Perform calibrations and scheduled preventive maintenance on analytical and other laboratory instruments.
  • Test control systems/instruments and assist in validation of new and existing manufacturing facilities
  • Maintain a safe work environment; work in a safe manner following all safety SOP's and wear Personal Protective Equipment as required
  • Maintain accurate record keeping equipment and systems cGMP compliant at all times
  • Work independently and make sound judgments regarding work methods and tools and support the Corporations, Companies, Departments and Personal goals and objectives
  • Procures spare parts, labor, special tools, calibration equipment, contracts, documentation (such as CRRA's, SOP's) and equipment availability for work execution.
  • Possesses a mechanical acumen including HVAC, Purified Water system, facilities utilities, P&ID's, schematics and equipment specifications is a must.
  • Possesses electrical acumen including understanding electrical single line diagrams, wiring diagrams, controls schematics and equipment specifications is a must.
  • Act as the point person to the Instrumentation & Calibration technicians while working closely with the manager to ensure strategy planning, implementations of plans, resolving problems while maintaining production quality.
  • Have an understanding of quality systems; Change Control, Deviations, CAPA's, Audits activities, Computerized Maintenance Management Systems required.
  • Is accountable to the Senior Manager, Facilities and the team for facilities performance
  • Other duties as assigned


Knowledge and Skills
  • Self-starter with superior analysis and problem solving skills ranging from simple to complex situations
  • Be forward thinking the ability to work with system & technical metrics, identify variances & deficiencies while improving maintenance program and performance.
  • Has a high energy level and a positive outlook coupled with the requisite "can do" attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles
  • Willing to think outside of the box and adapt best methodologies to our small, but growing environment
  • Be proficient in MS Office suite
  • Demonstrates proficiency in current Good Manufacturing Practices (GMPs).
  • Possesses good communications skills to explain information and influence others to secure successful implementation of Facilities and Engineering programs and directives as assigned.
  • Able to build and manage a team as well as train entry-level personnel
  • Willing to put internal customer needs first


Requirements:
  • 8+ years of relevant experience and a high school diploma.
  • Must possess full knowledge of the fundamental operating principles of industrial process instrumentation and process control systems
  • Be proficient in ISA standards and practices for instrumentation
  • Understands impact of equipment and system changes and alarms through DCS, Delta V, and/or local loop controllers
  • Knowledge of and ability to use Computerized Maintenance and Calibration Management Systems
  • Previous experience working in biotech, biopharmaceuticals, or highly regulated manufacturing environments is desirable.
  • Must be able to lift, carry, push and/or pull 100 lb. of equipment or supplies
  • Must be able to stand, walk, squat, bend, kneel, climb, and or reach for 75% of a shift
  • collaborative work environment
  • Control automation and PLC experience is a plus
  • Has the ability to write department operational/maintenance and engineering SOP's
  • Business travel will be required.


Does this sound like you? If so, please apply today!

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IND123

Kite 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. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

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