Position Title:

Environmental Monitoring Technician Work Location:

Hillsboro, OR 97124

Assignment Duration:

12 months

Work Arrangement:

Onsite Position Summary:

• 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.

Key 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

Qualification & Experience:

•

Education:

B.S./B.A.

degree in a relevant scientific discipline (e.g., Biology, Microbiology, Chemistry) OR previous experience performing Environmental 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. •

Communication:

Strong verbal and written communication skills to effectively notify management of quality or regulatory issues •

Flexibility:

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