Careers

Description:

The Environmental Monitoring department performs the functions associated with sampling, initiating tests, collecting and evaluating test results related to defined quality parameters for surface, air, personnel, product and utility systems such as compressed gases and WFI. The Specialist oversees EM functions and personnel, schedules projects, tasks and personnel, assists in training EM technicians and gown training of all aseptic personnel.

1. Aseptic Certification & Compliance

• Attain and maintain aseptic gowning certification for all designated cleanroom areas.
• Demonstrate consistent compliance with gowning procedures, aseptic techniques, and badge access protocols.

2. Environmental Monitoring Execution

• Perform routine and non-routine environmental monitoring in ISO 8 and sterile manufacturing areas, including gown sampling, area clearance, product sampling, and media fill qualifications.
• Conduct utility sampling (e.g., compressed gases, pass-throughs) and support requalification activities.

3. Sample Preparation & Equipment Handling

• Prepare, autoclave, and manage supplies and equipment required for EM activities, including totes, tubing, labels, documents, and sterile equipment.
• Operate and maintain EM sampling and testing equipment, including sonication and manual verification tools.

4. Data Management & Documentation

• Accurately enter, verify, and trend environmental data using systems such as MODA, FacilityPro, MasterControl, and TrackWise.
• Write clear, concise observational memos and ensure data integrity across electronic records and spreadsheets.

5. SOP & Protocol Compliance

• Read, understand, and follow SOPs, protocols, and departmental procedures.
• Participate in the writing, review, and revision of SOPs and protocols to support operational excellence and compliance.

6. Operational Support Across Manufacturing Areas

• Provide EM support during setup, middle-of-run, and end-of-run activities in SVP1, SVP2, CTM, and SLM suites.
• Ensure timely and accurate sampling during production and qualification runs, including gown sampling and sterile suite monitoring.

7. 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.

8. Deviation & Change Control Support

• Initiate and support investigations, deviations (TrackWise), TPIRs, and EMIRs as required.
• Contribute to change management processes and maintain compliance with quality systems.

9. 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.

10. Manufacturing Core Certification

• Must be fully core certified in at least two manufacturing cores.

Full core training in four manufacturing areas is desirable and supports broader operational flexibility

Skills/Eligibility:

Qualifications:

• Bachelors of Science required
• 2 years Environmental Monitoring or Pharma manufacturing experience required with HS/GED or 1-year pharma or lab experience with a Bachelor’s of Science degree required
• Lead experience required
• Working Knowledge in MS Word and excel and PowerPoint required
• Navigation of computers & systems required
• Ability to lift 25 lbs unassisted, pushing, pulling, prolonged standing and sitting, twisting required
• Must be able to perform aseptic gowning to meet specified criteria; work in an aseptic environment for periods of time, which includes wearing a sterile garment; tolerate periods of bending and climbing stairs, noise, and wet working surfaces required