Environmental Monitoring Qualification Specialist

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

Employment Model:
100% Onsite

Employment Type: Contract

Partner: Pro Quality Network

Industry: Pharmaceutical / GMP-Regulated Manufacturing

Pro Quality 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.

• 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 clean rooms, 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.

• 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.

• 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.

• 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