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Instrumentation & Controls Technician

Full Time

Website Serán Biosciences

Serán Biosciences specializes in bringing the most challenging drug therapies to market through a comprehensive set of drug-development services and GMP manufacturing.  As an Instrumentation/Calibration Technician you will report to the Calibration and Maintenance Supervisor within the Manufacturing Sciences & Technology Department.  In this role, you will be on the ground floor of developing the GMP calibration program at Serán.  You will have the opportunity to participate in building the calibration and maintenance program, develop calibration practices and procedures, manage calibration vendors/contracts (as necessary), identify critical spare parts, and work collaboratively with our customer groups to provide best-in-class service in support of our mission. Candidates with a minimum of one year of experience performing calibrations in a cGMP environment are encouraged to apply.

Duties and Responsibilities

  • Calibrate GMP manufacturing instrumentation such as incubators, temperature storage chambers, life safety gas detection monitoring equipment, controlled temperature storage equipment, and analytical lab/manufacturing equipment
  • Understand and perform calibration on Temperature, Pressure, Conductivity, UV, Analytical Balances, Scales, Vacuum, pH, ORP, Timers, Liquid/Gas flow, and Gas Detector instrumentation
  • Execute corrective maintenance work orders on production, facility, and utility systems in a GMP environment (such as HVAC, RODI water, spray dryers, tablet presses, pharmaceutical tablet production systems, analytical balances, clean in place (CIP) machines), in a compliant and complete manner
  • Assist in setup and operation of CMMS system (as a GMP validated system) for all calibrated/maintained assets at the site
  • Maintain applicable data in the CMMS, such as asset records, calibration data, and events/schedules
  • Coordinate/schedule calibrations with end user groups (e.g. manufacturing, quality control) to ensure minimal impact to operations
  • Oversee calibrations performed by vendors, including review of all service/calibration reports for accuracy and to ensure compliance with Serán’s requirements
  • Provide input on the selection of calibration standards, calibration methodology, and test points/tolerances/intervals to align with industry best practices and any relevant guidance
  • Provide after-hours on-call support, due to failure of equipment/instrumentation
  • Execute, document, and close work orders in a compliant and complete manner
  • Assist with managing the spare parts inventory (MRO), such as sourcing parts, determining stock to keep on hand, ordering, and receiving parts
  • Upkeep and stocking of maintenance/calibration shop as consistently ready to perform cGMP calibrations on cell and gene therapy manufacturing and analytical instruments
  • Understanding and knowledge of PLC, Microprocessor, and control system logic
  • Utilize the site’s Equipment Monitoring System to monitor, troubleshoot, and calibrate instrumentation on environmental chambers
  • Provide training to internal and external resources, as necessary, to ensure personnel are qualified to perform calibrations
  • Ensure compliance with all applicable GMP and safety requirements while performing tasks
  • Initiate, assess, and own change controls, CAPA’s, and deviations in Serán’s Quality Management System
  • Maintain current state of training with cGMP SOPs
  • Other duties as assigned

Required Skills and Abilities

  • Understanding and knowledge of PLC, Microprocessor, and control system logic
  • Experience using/setting up CMMS systems in FDA-regulated industries
  • Experience in starting up a GMP facility
  • Experience managing/interacting with calibration vendors
  • Ability to manage competing priorities while delivering a high level of service
  • Excellent verbal and written communication skills with demonstrated comprehension of need to clearly document GMP calibration activities
  • Direct experience interacting with regulatory agencies (e.g. FDA, EMEA) during inspections preferred
  • Excellent organizational skills and attention to detail
  • Ability to function well in a high-paced and at times stressful environment
  • Proficient with Microsoft Office Suite

Education and Experience

  • Requires a 2-year technical degree or higher in instrumentation, automation, or related discipline
  • 1-5 years’ experience performing calibrations in a cGMP environment

Physical Requirements

  • Prolonged periods of sitting or standing at a desk and working on a computer
  • Ability to lift a minimum of 50 lbs
  • Ability to wear a respirator
  • This position will require work to be performed in utility/mechanical spaces, compressed gas delivery/storage areas, and cleanroom environments
  • May work in cold and wet environments at times
Compensation correlates to skills and experience presented by selected candidate. Visit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon.
Benefits Summary:
Serán employees accrue over four weeks of paid time off annually. Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period. Various health plans allow employees to find the best coverage for their individual or family needs. Serán fully funds employees and their household with dental, vision and one medical plan option. Serán covers each employee with basic life and long-term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees’ wellbeing.

To apply for this job please visit jobs.lever.co.

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