Environmental Monitoring (EM) / EMPQ Specialist – Contract Role
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 strategy & execution
- Environmental Monitoring Performance Qualification (EMPQ)
- Cleanroom qualification & contamination control
- Risk-based EM program design
- Aseptic operations support
- GMP compliance (FDA, EU Annex 1, WHO, ISO)
- Data analysis, trending & program optimization
- Technical writing, protocol development & documentation accuracy
How to Apply
If you meet the qualifications and are ready to support a major pharmaceutical initiative, we encourage you to apply with your updated resume through the job description link.