Environmental Monitoring and Sampling Supervisor

About the Position

Environmental Monitoring and Sampling Supervisor

Juncos, PR, Puerto Rico

Full Time

Experienced

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About the Company

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.

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Responsibilities

• 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, cleanrooms, 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 monitoring reports, contamination control assessments, and annual product quality review inputs.
• Evaluate and implement continuous improvement initiatives to enhance sampling efficiency, contamination control processes, laboratory practices, and environmental monitoring strategies.
• Coordinate environmental monitoring activities during shutdowns, maintenance activities, construction projects, facility modifications, and commissioning or qualification activities.
• Manage departmental resources, supplies, equipment, and budget requirements to support uninterrupted monitoring and sampling operations.
• Ensure all activities are conducted according to safety regulations, biosafety requirements, environmental health standards, and company policies.
• Serve as the primary point of contact and Subject Matter Expert (SME) for Environmental Monitoring and Utilities Sampling programs during inspections, audits, and regulatory interactions.

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Requirements

• Bachelor’s Degree in Sciences; Biology, Biotechnology, Microbiology, Industrial Microbiology or Engineering disciplines is highly preferred OR Associate’s degree plus 6 years of directly experience in a quality role within the regulated industry (pharmaceutical, medical device or biotechnology) OR High School degree plus 8 years of directly in a quality role within the regulated industry (pharmaceutical, medical device or biotechnology.
• At least five (5) years of directly experience in a manufacturing operation or quality role in Parenteral or Pharmaceutical Industry.
• Previous experience with three (3) to five (5) years of in a supervisory / managerial position, with at least three (3) years of experience in Parenteral or Pharmaceutical Industry.
• Two (2) years of experience in GMP Environmental Monitoring or Utilities Sampling activities is preferred. Experience in clean room environmental monitoring and aseptic technique is a preferred.
• Proven technical knowledge in Parenteral or Pharmaceutical environmental monitoring program, aseptic operations, isolators, sanitization and sterilization process.
• Must have knowledge in compendium requirements (e.g.: FDA, EMEA), cGMP, GLP, and FDA regulations and the ability to interpret and apply them.
• Fully bilingual (Spanish/English) communication skills, both written and verbal. Excellent technical writing skills (English/Spanish).
• Strong leadership skills, time management and planning.

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Nice to Have

• Leadership
• Technical Writing
• Aseptic Operations
• Cleanroom Environments

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We Offer

• Competitive salary
• Comprehensive benefits package
• Opportunities for professional growth and development
• Collaborative and inclusive work environment

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Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.

Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.