Environmental Monitoring Technician

Environmental Monitoring Technician – Hillsboro, OR – 06 Months Position Overview

As an Environmental Monitoring (EM) Technician, you will be a key member of the Analytical Development and Testing (ADT) team within the Hillsboro Innovative Therapies (HIT) organization. This role supports the clinical manufacturing of next-generation Cell and Gene Therapies (CGT) by ensuring manufacturing environments remain in a validated state of control.

• Sample Collection:
  Execute viable (air/surface), non-viable particulate, and critical utility monitoring in both cleanroom and unclassified environments
• Compliance & Documentation:
  Maintain strict adherence to current Good Manufacturing Practices (cGMP), Standard Operating Procedures (SOPs), and internal quality standards
• Data Management:
  Utilize the Laboratory Information Management System (LIMS) for sample scheduling, data entry, and results reporting
• Excursion Response:
  Coordinate response activities when environmental limits are exceeded, including assisting with investigation data and restart activities
• Operational Support:
  Support the maintenance of operational areas by managing consumables and ensuring EM equipment is within calibration before use
• Safety:
  Adhere to all gowning and Personal Protective Equipment (PPE) requirements mandated for classified manufacturing spaces
• Routine Lab Maintenance:
  Disinfectant and reagent preparation, equipment cleaning and maintenance, lab supply stocking

• Education:
  
  B.S./B.A. degree in a relevant scientific discipline (e.g., Biology, Microbiology, Chemistry) OR previous experience performing EM
• Technical Knowledge:
  Basic understanding of cGMP regulations and aseptic practices is preferred
• Physical Demands:
  Ability to work in a cleanroom environment, which includes prolonged periods of standing or sitting. Must be able to perform frequent lifting (up to 25 lbs.), bending, reaching, and twisting
• Communication:
  Strong verbal and written communication skills to effectively notify management of quality or regulatory issues
• Flexibility:
  Willingness to work flexible hours, including various shifts and weekends, to meet clinical manufacturing schedules