Environmental Monitoring; EM Associate

Job Description

Jubilant Hollister Stier LLC,
Spokane’s Largest Manufacturing Company
, and well-established member of the business community, provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. Jubilant Hollister Stier is a nationally recognized contract manufacturer of sterile injectable vials, and lyophilized products. The Allergy business is a worldwide leader in the manufacture of allergenic extracts, targeted primarily at treating allergies and asthma. Jubilant Hollister Stier is a proud member of the Jubilant Pharma family.

Our Promise:
Caring, Sharing, Growing

We will, with the utmost care for the environment and society, continue to enhance value for our customers and stakeholders by providing innovative products and economically efficient solutions through growth, cost effectiveness and wise investment of resources.

The Environmental Monitoring (EM) Associate is responsible for the monitoring of biological and airborne particulate levels in clean room environments for the purpose of preparation, compounding, and production of sterile injectable drug and drug products. The EM Associate will be trained on proper aseptic behavior, sanitization processes, and donning of sterile gowns. Associates will be required to have an aptitude for reading detailed procedures, clear documentation practices, and operating several environmental software applications;

thus, digital literacy is highly encouraged for this position. Additionally, EM Associates will need adequate dexterity to don sterile gowns, requiring a level of coordination to balance while ensuring garments control while dressing. Additional responsibilities will include the collection of test samples aseptically, preparation of tools, equipment, and supplies which will be used in a clean room setting, and aseptic observations of aseptic technique.

1. Environmental and Product Sampling

a. Collect environmental and product samples within ISO 8 cleanroom environments during extended shifts (8, 10, or 12 hours).

b. Perform gown sampling, area clearance, and product sampling in accordance with departmental procedures and GMP standards.

2. Monitoring Equipment and Software Use

a. Operate environmental monitoring and testing equipment, including associated software applications such as MODA, to compile and manage sample data.

b. Maintain equipment readiness and report any issues or deviations promptly.

3. Preparation and Sterilization of Supplies

a. Prepare and organize sampling supplies including totes, labels, documents, tubing, and equipment.

b. Operate autoclaves to sterilize materials and ensure readiness for sampling activities.

4. Sample Processing and Incubation

a. Perform verification and incubation of environmental samples.

b. Ensure proper documentation and traceability throughout the sample lifecycle.

5. Documentation and Data Integrity

a. Accurately enter and verify sample data using MODA and other EM systems.

b. Maintain high standards of data integrity and completeness in all records and observational memos.

6. SOP Compliance and Training

a. Read, understand, and follow applicable SOPs and departmental protocols.

b. Maintain current SOP training status and complete all required modules within the first six months.

7. Aseptic Gowning Certification

a. Obtain and maintain aseptic gowning certification for entry into controlled environments.

b. Demonstrate proper gowning technique and compliance with badge access protocols.

8. Support for Requalification and Media Fill Activities

a. Assist in requalification sampling and media fill qualification processes as directed.

b. Ensure sampling accuracy and adherence to procedural requirements.

9. Cleanroom Entry and Alarm Response

a. Follow badge access protocols for smock and coverall use in designated areas.

b. Respond appropriately to BAS user alarms and maintain situational awareness in cleanroom environments.

• Previous work experience with strong work ethic (some overtime would be required)
• Minimum 1-year pharmaceutical or laboratory experience desired
• Knowledge of cGMP’s, operation of autoclaves, aseptic technique, and basic…