(EMPQ) Environmental Monitoring Performance Qualification

(EMPQ) Environmental Monitoring Performance Qualification Our client is expanding new Drug Product facility in East Greenbush, NY and require two experienced Validation/Environmental Monitoring (EMPQ) Performance Qualification specialists to design, execute, and document PQ activities. These roles will generate protocols, collect data, and record results with a focus on both dynamic and static environmental conditions. The incumbents will be responsible for air testing (viable and non-viable), surface testing, personnel monitoring, and comprehensive environmental and utility testing (temperature, relative humidity, differential pressure, air quality). The goal is to ensure facility readiness, compliance with GMP, and readiness for regulatory review. This is a one + year assignment at an hourly rate of $50.00 Key Responsibilities: Coordinate and collaborate with QC on Air Testing for Viable and Non-Viable (particulates) in dynamic and static environments; document methods, acceptance criteria, and trending. Review Surface Testing (settle plates, contact plates, surface swab) to verify cleaning and hygiene status; record results and investigate variances. Implement Personnel Monitoring programs (e.g., passive air sampling, badge monitoring, or equivalent) to ensure worker exposure and safety metrics meet regulatory expectations. Execute Environmental and Utility Testing, including physical parameters: Temperature and Relative Humidity (T/RH) monitoring Differential Pressure verification across cleanroom interfaces and zones Air Quality assessments (air cleanliness classifications, aerosol counts as applicable) Generate, execute, and document IQ/OQ/PQ protocols for new rooms, expansions, HVAC systems, cleanrooms, and support equipment; ensure alignment with regulatory requirements (FDA, EMA, ICH guidelines) and internal SOPs. Collect, review, and archive data with emphasis on data integrity (ALCOA) and audit-ready documentation. Prepare and present evacuation of data for PQ reports, CAPAs, deviations, and change controls; support regulatory inspections and client audits. Collaborate with Engineering, Facilities, Quality, Compliance, and Manufacturing to ensure qualification activities align with project timelines and quality expectations. Mentor and train junior team members or contractors on EM methods, PQ procedures, and GMP expectations. Identify opportunities for process optimization and efficiency in EM/PQ activities and documentation. Qualifications: Education: Bachelor's degree in Life Sciences, Engineering, Chemistry, or a related field. Master's degree preferred. Experience: 3–5 years of progressive experience in pharmaceutical validation and environmental monitoring, with direct exposure to room expansions or new facility commissioning preferred. Technical Skills: Deep knowledge of GMP/GLP, ICH guidelines (Q7, Q9, Q10, Q11 as applicable), and US/EU regulatory expectations. Demonstrated experience with IQ/OQ/PQ for facilities, utilities (HVAC, cleanrooms, temperature/humidity control, differential pressure), and related equipment. Proficient in EM programs for viable and non-viable particle counting, microbiological monitoring, surface sampling, and cleanroom classifications. Experience with air testing for both dynamic and static environments; knowledge of sampling strategies and data interpretation. Familiarity with personnel monitoring methods and regulatory expectations. Proficiency with data management systems (LIMS, MES, ERP) and data integrity principles. Statistical analysis skills and experience with qualification planning, trend analysis, and acceptance criteria justification. Regulatory & Documentation: Proven ability to author, review, and maintain validation PDFs, protocols, risk assessments, change controls, deviations, CAPAs, and SOPs; audit-ready documentation. Communication: Strong written and verbal communication; ability to present technical information clearly to cross-functional teams and regulators. Project Management: Demonstrated ability to manage multiple PQ activities simultaneously and meet tight timelines. Certifications (preferred): CQA (ASQ) or other GMP/Quality Assurance certifications; cleanroom certification; Six Sigma or equivalent process improvement credentials. Scope of Work (Sample Deliverables): Validated IQ/OQ/PQ protocols for new rooms, expanded spaces, HVAC systems, cleanrooms, and associated utilities. EM data sets including particle counts (viable and non-viable), surface sampling results, and personnel monitoring results with trend analyses. Temperature, humidity, differential pressure logs and validated setpoints/alarms. PQ reports, cleanroom classifications, CAPAs, deviations, and change controls with complete documentation packages. Training materials and standard operating procedures related to EM and PQ activities. Final readiness assessment for regulatory inspection and client audits. Key Metrics: On-time completion of PQ activities and protocol execution Completeness and accuracy of EM data and documentation Timely CAPA closure and deviation resolution Regulatory inspection readiness and data integrity compliance Adherence to project budgets and resource optimization JSG (Johnson Service Group, Inc.)