Environmental Monitoring Performance Qualification Specialist

ProQuality Network; Florida; On-site; USD 120,000 - 180,000; Part time

Job summary

ProQuality Network is supporting a major pharmaceutical company in Tampa, Florida, redesigning and strengthening its Environmental Monitoring (EM) program, with a focus on EMPQ activities in a highly regulated sterile manufacturing environment.

The role requires 7+ years of EM experience, a Bachelor’s in a life sciences field, and strong data analysis, regulatory awareness, and CAPA-oriented problem solving to ensure cGMP compliance on site.

Qualifications

• Bachelor's degree in Microbiology, Biology, Biotechnology or Life Sciences.
• 7+ years of hands-on Environmental Monitoring in pharma/biotech sterile settings.
• Experience with EMPQ or similar qualification activities.
• Strong understanding of contamination control and cleanroom practices.
• Familiarity with FDA/EMA/EU Annex 1/WHO/ISO standards and global regs.
• Analytical, documentation, and problem-solving skills for EM/EMPQ data.
• Ability to work onsite independently in a highly regulated environment.

Responsibilities

• Lead EMPQ activities: planning, execution, data analysis, reporting.
• Redesign and optimize the Env Monitoring program.
• Develop risk-based EM/EMPQ strategies aligned with global guidelines.
• Perform environmental monitoring in aseptic/classified cleanrooms.
• Evaluate cleanrooms, trends, and contamination control improvements.
• Do data trending and periodic EM/EMPQ reporting for continuous improvement.
• Collaborate with QA, QC Microbiology, Validation, and Sterility teams.
• Investigate deviations and recommend CAPAs under cGMP standards.

Skills

EMPQ leadership

Risk-based EM design

Aseptic operations support

GMP compliance

Data analysis

Education

Bachelor's in Microbiology/Life Sciences

Tools

LIMS

EM software systems

Digital trending tools

Job description

Environmental Monitoring Performance Qualification Specialist

Location: Tampa, Florida (Local residents or nearby areas within commuting distance)

Employment Model: 100% Onsite

Employment Type: Contract

Partner: ProQuality Network

Industry: Pharmaceutical / GMP-Regulated Manufacturing

Summary

ProQuality Network is supporting a major pharmaceutical company on a critical initiative focused on redesigning and enhancing its Environmental Monitoring (EM) program, including the execution and optimization of Environmental Monitoring Performance Qualification (EMPQ) activities. We are seeking experienced EM/EMPQ professionals who can provide deep technical expertise, strengthen contamination control strategies, and support aseptic operations. This is a high-impact, high-visibility project ideal for candidates who excel in regulated, sterile manufacturing environments. Please note: This is a 100% onsite opportunity in Tampa, Florida.

Key Responsibilities

• Lead and support Environmental Monitoring Performance Qualification (EMPQ) activities, including planning, execution, data analysis, and reporting.


• Contribute to the redesign and optimization of the site's Environmental Monitoring program.


• Develop and implement risk-based EM and EMPQ strategies aligned with FDA, EU Annex 1, and global regulatory guidelines.


• Conduct routine and specialized environmental monitoring within aseptic and classified cleanroom environments.


• Evaluate and qualify cleanrooms, assess environmental trends, and identify contamination control improvements.


• Perform data trending, EM/EMPQ analysis, and develop periodic reports to support continuous improvement and compliance.


• Partner with QA, QC Microbiology, Validation, Sterility Assurance, and Aseptic Operations to strengthen contamination control practices.


• Investigate EM/EMPQ deviations, excursions, and non-conformances, and recommend scientifically sound CAPAs.


• Ensure strict adherence to cGMP standards, regulatory expectations, and internal quality procedures related to EM and EMPQ activities.

Qualifications

• Bachelor's degree in Microbiology, Biology, Biotechnology, Life Sciences, or a related scientific field.


• 7+ years of hands-on Environmental Monitoring experience in pharmaceutical, biotech, or sterile manufacturing environments.


• Demonstrated experience with Environmental Monitoring Performance Qualification (EMPQ) or similar qualification activities.


• Strong understanding of contamination control, cleanroom classification, aseptic behavior, and sterile practices.


• Familiarity with FDA, EMA, EU Annex 1, WHO, ISO standards, and global regulatory expectations.


• Strong analytical, documentation, and problem-solving skills with the ability to interpret and communicate EM/EMPQ data.


• Ability to work independently onsite in a highly regulated and compliance-driven environment.

Preferred Experience

• Experience supporting EM program redesign, site remediation, EMPQ development, or sterility assurance projects.


• Working knowledge of aseptic process simulations, validation, and cleanroom qualification protocols.


• Proficiency with EM software systems, LIMS, or digital trending tools.

Core Competencies & Skills

• Environmental Monitoring Performance Qualification (EMPQ)


• Risk-based EM program design


• Aseptic operations support


• GMP compliance (FDA, EU Annex 1, WHO, ISO)


• Data analysis, trending & program optimization