CQV - Environmental Monitoring Performance Qualification

EMPQ Specialist CQV (Environmental Monitoring Performance Qualification)
Location: Boston, MA
Job Type: Full-Time / Contract 

Job Summary

We are seeking a skilled EMPQ Specialist to support CQV (Commissioning, Qualification, and Validation) efforts focused on Environmental Monitoring Performance Qualification in a regulated pharmaceutical manufacturing environment. The EMPQ Specialist will be responsible for planning, executing, and documenting EMPQ activities to ensure cleanroom compliance, regulatory alignment, and process readiness for GMP manufacturing.

Key Responsibilities

• Develop, review, and execute Environmental Monitoring Performance Qualification (EMPQ) protocols for cleanrooms, classified areas, and controlled environments.

• Oversee EMPQ execution activities such as viable and non-viable particle monitoring, microbial surface sampling, and air/surface qualification.

• Coordinate with cross-functional teams (validation, quality, microbiology, manufacturing, and engineering) to ensure seamless qualification execution.

• Interpret EMPQ results and prepare detailed reports, including data analysis, trending, and summary of findings.

• Ensure alignment with GMP regulations, ISO 14644 standards, EU Annex 1, and FDA guidelines.

• Support HVAC system qualification and integration of environmental monitoring equipment and data.

• Assist in deviation investigations, change controls, and CAPA related to EMPQ activities.

• Participate in audits and provide documentation to demonstrate environmental control and monitoring program compliance.

• Maintain accurate records and documentation in accordance with internal procedures and regulatory expectations.

Qualifications

• Bachelor's degree in Microbiology, Life Sciences, Engineering, or a related field.

• 5 plus years of experience in environmental monitoring qualification within a GMP-regulated pharmaceutical or biotech environment.

• Solid understanding of cleanroom classification (ISO 14644), environmental monitoring strategies, and microbial control.

• Experience in developing and executing EMPQ protocols (viable/non-viable monitoring, airflow visualization, etc.).

• Familiarity with HVAC and facility support systems affecting cleanroom performance.

• Strong written and verbal communication skills and meticulous attention to detail.

• Proficient in Microsoft Office and GMP documentation systems.

Preferred

• Experience with Annex 1 revision implementation.

• Familiarity with electronic validation platforms such as KNEAT.

• Knowledge of aseptic techniques and contamination control strategies.