Environmental Monitoring and Sampling Supervisor

Job Description

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets:
United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.

• Supervise, coordinate, and oversee all Environmental Monitoring (EM) and utilities sampling activities performed in manufacturing, laboratory, warehouse, and support areas to ensure compliance with cGMP regulations, company procedures, and regulatory agency requirements.

• Lead and manage the Environmental Monitoring team, including scheduling, work assignment, performance management, training, coaching, and development of personnel to ensure operational excellence and compliance.

• Ensure the execution of viable and non-viable environmental monitoring activities in classified manufacturing areas, clean rooms, aseptic processing suites, isolators, controlled environments, and supporting facilities.

• Oversee utilities sampling programs including Water for Injection (WFI), Purified Water (PW), clean steam, compressed gases, and other critical utility systems to ensure compliance with established specifications and regulatory standards.

• Verify the accurate collection, documentation, review, and approval of environmental monitoring and sampling data in accordance with ALCOA+, Data Integrity principles, and Good Documentation Practices (GDP).

• Review environmental monitoring trends, utility sampling results, and microbiological data to identify adverse trends, process shifts, and potential contamination risks.

• Lead investigations related to environmental monitoring excursions, alert/action level exceedances, out-of-trend results, contamination events, and utility system deviations.

• Partner with Quality Assurance, Manufacturing, Engineering, Validation, Facilities, and Microbiology teams to assess product impact, determine root causes, and implement effective corrective and preventive actions (CAPAs).

• Maintain oversight of cleanroom classification programs, routine certifications, airflow studies, HEPA filter integrity testing, and environmental qualification assessments.

• Provide technical expertise regarding aseptic practices, contamination control strategies, sterilization processes, sanitization programs, cleanroom behavior, and microbiological controls.

• Develop, revise, review, and approve Standard Operating Procedures (SOPs), work instructions, protocols, risk assessments, forms, and technical reports associated with environmental monitoring and utilities sampling programs.

• Ensure personnel qualification programs are maintained, including aseptic gowning qualifications, cleanroom behavior training, sampling techniques, and contamination control practices.

• Monitor department performance metrics and establish Key Performance Indicators (KPIs) related to environmental monitoring compliance, investigation closure, sampling execution, data review timeliness, and training effectiveness.

• Support internal audits, client audits, regulatory inspections, and corporate quality assessments by providing documentation, technical presentations, responses, and subject matter expertise.

• Ensure compliance with client SOP's, GMP's, and other applicable regulatory requirements governing environmental monitoring programs and microbiological control systems.

• Review and approve environmental monitoring trend reports, utility…