Environmental Monitoring Technician

Title: Environmental Monitoring Technician
Location: Hillsboro, OR 97124 (Onsite)
Duration: 12 Months
Description:

• 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.

Primary Responsibilities

• 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

Qualifications & Requirements

• Education: B.S./B.A. degree in a relevant scientific discipline (e.g., Biology, Microbiology, Chemistry) OR previous experience performing Enviromental Monitoring.
• 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

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