Specialist - EM

Job Description

The Environmental Monitoring department oversees sampling, testing, and evaluation of environmental quality parameters for surface, air, personnel, product, and utility systems such as compressed gases and WFI. The specialist manages EM functions and personnel, schedules projects, trains EM technicians, and oversees gown training for aseptic staff.

• Aseptic Certification & Compliance Attain and maintain gowning certification for cleanroom areas. Demonstrate consistent compliance with gowning procedures, aseptic techniques, and badge access protocols.
• Environmental Monitoring Execution Perform routine and non‑routine monitoring in ISO 8 and sterile areas, including gown sampling, area clearance, product sampling, media fill qualifications, and utility sampling. Support requalification activities.
• Sample Preparation & Equipment Handling Prepare, autoclave, and manage supplies and equipment such as totes, tubing, labels, and sterile instrumentation. Operate and maintain EM sampling and testing equipment.
• Data Management & Documentation Accurately enter, verify, and trend environmental data using systems such as MODA, Facility Pro, Master Control, and Track Wise. Write clear, concise observational memos and ensure data integrity.
• SOP & Protocol Compliance Read, understand, and follow SOPs, protocols, and departmental procedures. Participate in writing, reviewing, and revising SOPs to support operational excellence.
• Operational Support Across Manufacturing Areas Provide EM support during set‑up, mid‑run, and end‑run activities in SVP1, SVP2, CTM, and SLM suites. Ensure timely sampling during production and qualification runs.
• Training & Scheduling Support Train or coordinate training for EM personnel, including gowning certification and system use. Assist in scheduling EM tasks and personnel in collaboration with the EM Supervisor.
• Deviation & Change Control Support Initiate and support investigations, deviations (Track Wise), TPIRs, and EMIRs. Contribute to change management processes and maintain compliance with quality systems.
• Leadership & Backup Responsibilities Provide backup support to the EM Supervisor on departmental issues and scheduling. Demonstrate initiative in resolving issues, supporting audits, and driving departmental goals.
• Manufacturing Core Certification Must be fully core certified in at least two manufacturing cores. Full core training in four manufacturing areas is desirable for broader operational flexibility.

• Bachelor of Science required.
• 2 years of Environmental Monitoring or pharmaceutical manufacturing experience required.
• Lead experience required.
• Working knowledge of MS Word, Excel, and PowerPoint required.
• Computer and systems navigation skills required.
• Ability to lift 25 lbs unassisted, push, pull, stand, sit, and twist required.
• Must perform aseptic gowning to specified criteria and work in an aseptic environment for periods of time, tolerating bending, climbing stairs, noise, and wet surfaces.

Spokane, WA – On Site, Full‑Time.

Monday – Friday, 4:30 AM – 4:30 PM.

Hiring Wage: $38 per hour with a shift differential of 2.5%, plus opportunities for growth, promotion, and annual raises.

Benefits:

• Medical, Dental & Vision coverage.
• Flexible Spending Accounts (FSA) and Health Savings Accounts (HSA).
• Life & AD&D Insurance.
• Short‑Term & Long‑Term Disability Insurance.
• Employee Assistance Program.

Jubilant Hollister Stier is an EEO/AA Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.