QC Environmental Monitoring (EM) Technician - Site Based, Redmond, WA

Role Summary

QC-Environmental Monitoring (EM) Technician is part of the Quality Control team responsible for routine sampling of facility water, air, and surface samples in controlled environments, including ISO classified cleanrooms, to support GMP manufacturing activities for biotherapeutic products. This role involves traveling between Redmond, WA and Seattle, WA facilities and requires collaboration across QA, Manufacturing, and Facilities, with a focus on ensuring data integrity, compliance, and timely testing.

Responsibilities

• Travel to Redmond, WA and Seattle, WA facilities as applicable.
• Perform process and facility Environmental Monitoring: active/passive viable air sampling, surface sampling, and airborne particulate monitoring.
• Collect water samples (city, RO, DI, Milli-Q, WFI, etc.) from various valve locations.
• Maintain EM equipment and keep it up to date.
• Maintain metrics and contribute to routine EM trending and trending summary reports.
• Use Laboratory Information Management System (LIMS) electronic notebooks as needed.
• Order, inventory, stock supplies, clean lab spaces, and ship samples as needed.
• May perform microbiological lab support activities with additional training.
• Ensure aseptic technique during testing of controlled environments and utility systems.
• Work in compliance with site quality and safety guidelines; collaborate with team to complete tasks timely.
• Adapt to changing priorities and attend mandatory trainings.
• Perform investigations and other general duties as required; collaborate with QA, Manufacturing, Material Management, Facilities/Engineering to meet timelines.
• Assist in procedure and job aide revisions; provide support during routine and emergency facility activities; identify gaps and drive improvements.
• Participate in laboratory investigations, deviations, OOS, and CAPAs.
• Physical requirements: lift up to 50 pounds, kneel, crouch, twist, walk, bend, stoop, push, pull, reach; standing 8+ hours as needed.

Qualifications

• Associate degree or completion of college-level life science courses required.
• Strong interpersonal, analytical, problem-solving, and decision-making skills.
• Excellent written and verbal communication; detail-oriented with solid organizational skills.
• Strong data management and data integrity practices; proficient computer skills for data entry.
• Ability to work independently and with others; ability to interpret analytical/technical data.
• Willingness to learn regulatory requirements (ICH, CFR, FDA) related to environmental monitoring.
• Good hand-eye coordination; ability to wear PPE and gowning for ISO-8/ISO-7/ISO-5 spaces as required.
• Ability to use cleaning and disinfectant agents; able to stand or sit for long periods.
• Preferred: microbiology lab experience; experience in a cGMP QC/production environment.

Skills

• Environmental monitoring techniques and instrumentation
• Laboratory information management systems (LIMS)
• Water quality sampling (city, RO, DI, Milli-Q, WFI)
• Aseptic technique and cleanroom operations
• Data trending and interpretation
• Collaborative problem-solving and cross-functional coordination

Education

• Associate degree or equivalent college-level life sciences coursework required.

Additional Requirements

• Travel between Redmond, WA and Seattle, WA facilities as needed.
• Ability to lift up to 50 pounds and perform physically demanding tasks in cleanroom environments.