CQV - Environmental Monitoring Performance Qualification
PharmEng TechnologyBoston, Massachusetts, United States
Posted December 12, 2025
Full Time
About the Company
PharmEng Technology, now part of the Efor Group, delivers specialized compliance engineering services—Commissioning, Qualification, and Validation (CQV)—to the pharmaceutical, biotechnology, and healthcare sectors, drawing on 25 years of industry expertise. The firm designs, constructs, and validates facilities, utilities, equipment, and computer systems in strict adherence to cGMP, GEP, and GLP, covering areas such as API production, laboratory, and medical device manufacturing. Leveraging Efor’s global network of 3,000 experts across 12 countries, PharmEng combines worldwide best practices with local proximity to offer flexible, innovative, and cost‑effective solutions that meet regulatory and business demands. Its culture prioritizes quality, safety, and client partnership, ensuring customized, measurable outcomes for leading industry players.
Job Description
We are seeking a skilled EMPQ Specialist to support CQV efforts focused on Environmental Monitoring Performance Qualification in a regulated pharmaceutical manufacturing environment.
Requirements
- 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 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.
Benefits
- Full-time employment
- Contract employment