United Therapeutics-posted 10 days ago
Full-time • Mid Level
Onsite • Rtp, NC
1,001-5,000 employees

The Calibration Technician II will perform calibration, maintenance, and documentation of manufacturing equipment and instrumentation within a manufacturing facility. All duties must be performed in compliance with established policies and procedures in a cGMP-regulated facility. Perform, or oversee vendors performing, calibration of equipment, instruments, or systems in accordance with SOPs in order to reduce interruptions in the daily manufacturing schedules Perform basic to moderate troubleshooting and repair of instrumentation and related equipment or systems, escalating and seeking guidance on most complex tasks Complete proper documentation related to scheduled and unscheduled calibration events on all critical instrumentation and maintain records as required Assist in administering a computerized program that tracks calibration of all equipment associated with CGMP equipment and systems Assist with the writing or revising of SOPs, initiation of calibration protocols, deviation / failure investigations, and creation of reports, etc Assist with equipment validation activities associated with CGMP process Assist with maintaining spare parts inventory Review work performed by other staff, communicate problems and deficiencies, elicit corrections, and enforce company policy and procedures as they relate to calibration requirements Provide training to lower-level technicians on general and specific calibration procedures to support manufacturing operations in order to minimize downtime or delays

  • Perform calibration, maintenance, and documentation of manufacturing equipment and instrumentation within a manufacturing facility.
  • Perform, or oversee vendors performing, calibration of equipment, instruments, or systems in accordance with SOPs in order to reduce interruptions in the daily manufacturing schedules
  • Perform basic to moderate troubleshooting and repair of instrumentation and related equipment or systems, escalating and seeking guidance on most complex tasks
  • Complete proper documentation related to scheduled and unscheduled calibration events on all critical instrumentation and maintain records as required
  • Assist in administering a computerized program that tracks calibration of all equipment associated with CGMP equipment and systems
  • Assist with the writing or revising of SOPs, initiation of calibration protocols, deviation / failure investigations, and creation of reports, etc
  • Assist with equipment validation activities associated with CGMP process
  • Assist with maintaining spare parts inventory
  • Review work performed by other staff, communicate problems and deficiencies, elicit corrections, and enforce company policy and procedures as they relate to calibration requirements
  • Provide training to lower-level technicians on general and specific calibration procedures to support manufacturing operations in order to minimize downtime or delays
  • H.S. Diploma or General Education Degree (GED)
  • 4+ years of experience in a pharmaceutical, food, or chemical manufacturing environment as a calibration technician or equivalent role (is it a requirement for the experience to be in a pharmaceutical, food, or chemical manufacturing environment
  • Ability to become skilled in the use of calibration manager software
  • Strong working knowledge of CGMP regulations
  • Applied knowledge of pharmaceutical GMPs, FDA guidelines, and industry standards and the ability to apply GMP to company specific processes and products
  • Strong professional documentation skills
  • Ability to interact with other departments effectively
  • Ability to handle confidential company data, projects, information, etc.
  • Proficient in Microsoft office or equivalent
  • Strong written and verbal communication skills with the ability to objectively, accurately, and thoroughly convey complex issues in writing and produce a large volume of written materials independently
  • Associate Degree in engineering, life sciences, or other related technical field or equivalent military training and four years of instrumentation experience or the equivalent combination of education and experience
  • Knowledgeable in the use of Kaye data logging equipment and associated computer programming
  • Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more.
  • For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities
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