Environmental Monitoring (EM) / EMPQ Specialist jobs in United States
cer-icon
Apply on Employer Site
company-logo

Shoolin Inc · 12 hours ago

Environmental Monitoring (EM) / EMPQ Specialist

Shoolin Inc is seeking an experienced Environmental Monitoring (EM) / EMPQ Specialist to support and enhance Environmental Monitoring programs within a pharmaceutical, GMP-regulated sterile manufacturing environment. The role focuses on EMPQ execution, contamination control, cleanroom monitoring, and regulatory compliance.

Artificial Intelligence (AI)Big DataCloud ComputingInformation TechnologyInternet of ThingsSoftware
check
H1B Sponsor Likelynote
Hiring Manager
Aadil Shaikh
linkedin

Responsibilities

Lead and execute EMPQ activities including planning, execution, analysis, and reporting
Support redesign and optimization of Environmental Monitoring programs
Perform routine and specialized EM activities in aseptic and classified cleanroom areas
Trend and analyze EM/EMPQ data and prepare compliance documentation
Investigate EM deviations and excursions; recommend and support CAPAs
Collaborate with QA, QC Microbiology, Validation, and Aseptic Operations teams
Ensure adherence to cGMP requirements and internal quality procedures

Qualification

MicrobiologyEnvironmental MonitoringGMP regulationsContamination controlFDA regulationsData trendingCAPA developmentAseptic practicesCleanroom classificationLife Sciences

Required

Bachelor's degree in Microbiology, Biology, Life Sciences, or related field
Hands-on Environmental Monitoring experience in pharmaceutical GMP environments
Direct experience executing Environmental Monitoring Performance Qualification (EMPQ)
Strong understanding of contamination control, cleanroom classification, and aseptic practices
Working knowledge of FDA regulations and EU Annex 1
Experience with EM data trending, deviation investigations, and CAPA development
Ability to work independently in a 100% onsite, regulated setting

Company

Shoolin Inc

twittertwitter
company-logo
Shoolin-Inc staffing, specializes in providing world class recruiting services to companies in the Healthcare, IT, and Engineering sectors.

H1B Sponsorship

Shoolin Inc has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (56)
2024 (45)
2023 (48)
2022 (36)
2021 (29)
2020 (18)

Funding

Current Stage
Growth Stage
Company data provided by crunchbase