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Senior Calibration Technician

External
umojabiopharma logoUmojabiopharma · Louisville, CO
Full-timeOn-site2mo ago
ComplianceDocumentation
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Requirements

  • Knowledge and understanding of cGMP (current Good Manufacturing Practices), Food and Drug Administration, current pharmaceutical industry standards, and/or other regulations.
  • Experience in executing metrology systems and activities in pharmaceutical manufacturing or other regulated industries is preferred
  • Experience executing single‑point and multi‑point calibrations in pharmaceutical manufacturing or other highly regulated environments.
  • Independent and analytical thought process to evaluate options and make decisions (risk-based decision-making capability).
  • Ability to work effectively and efficiently in a collaborative manner across multiple functional areas.
  • Proficient in the operation of building automation systems including BMS, EMS, and standalone PLCs required for proper building, equipment, and system operation.
  • Experience working with Blue Mountain Regulatory Asset Manager CMMS is highly preferred.
  • Experience re

Benefits

Vision insurance

Additional Information

Umoja Biopharma is an industry-leading biotech with locations in Seattle, WA and Louisville, CO, focused on transforming the treatment of cancer with a novel integrated immunotherapy platform. Our vision is to develop off-the-shelf therapies capable of treating any tumor, any time. We are a diverse and growing team working in brand-new facilities in downtown Seattle, Washington and Louisville, Colorado, and we are looking for innovative thinkers who are excited by groundbreaking science and technology, and passionate about squaring up to the challenges inherent to cutting-edge drug development. We are committed to our core values and principles that support our overall mission and strongly invite applications from enthusiastic individuals who share our commitment and help position Umoja to deliver on our goals. We at Umoja believe in the importance of stories; we are looking for great people to join our team to help us create more stories for ourselves, for you, and most importantly for patients and their families. Umoja Biopharma - Your Body. Your Hope. Your Cure. POSITION SUMMARY Umoja Biopharma is seeking a Senior Calibration Technician to support the calibration and maintenance of measurement instrumentation at our state‑of‑the‑art lentiviral vector development and manufacturing facility in Louisville, Colorado. Primary responsibilities include performing routine and non‑routine instrument calibrations supporting production, laboratory, and facilities operations. The Calibration Technician works independently with minimal supervision to execute instrument calibrations for parameters including conductivity, pH, pressure, flow, temperature, speed, and mass in compliance with GxP and company quality standards. This role requires strong judgment and initiative to troubleshoot and resolve complex issues, as well as the ability to coordinate and oversee external service providers to ensure all work and documentation meet Umoja requirements. This role is an on-site position based out of our Louisville, CO location 5 days/week. CORE ACCOUNTABILITIES Specific responsibilities include: Coordinate and oversee external calibration service providers, including review of calibration certificates and resolution of documentation or compliance issues. Perform routine and non‑routine calibration of GMP and non‑GMP instrumentation supporting laboratory, manufacturing, utility, and facilities systems, using industry‑standard tools and methods. Ensure calibration and maintenance activities are performed and documented in compliance with GxP requirements, internal procedures, and applicable standards (e.g., ISO, ANSI, NIST), maintaining audit‑ready records. Troubleshoot calibration failures and instrumentation performance issues, identify corrective actions and support investigations in collaboration with cross‑functional partners. Legibly and accurately document work performed in Umoja's CMMS system in accordance with cGMP requirements in a timely manner. Optimize the time required to perform calibrations to minimize impact to routine operations. Contribute to continuous improvement efforts by identifying opportunities to optimize calibration execution, vendor performance, and site business processes. The successful candidate will have: High School diploma or equivalent, preferably including hands-on or vocational school training and a minimum of five (5) years of experience as an instrument technician in a manufacturing environment OR an Associate's degree in a technical field (instrumentation, controls, automation, electrical) with a minimum of three (3) years of relevant calibration or instrumentation experience. Hands‑on experience with advanced or specialized instrumentation such as RTDs and thermocouples, gas sensors, RH and differential pressure instruments, load cells, control valves, precision mechanical tools, and automated manufacturing equipment. Experience in GMP biopharmaceutical or cell and gene therapy manufacturing and/or testing facility.


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