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.

Essential Duties and 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.

Requirements and Qualiifcations

Bachelor’s Degree is required; 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.

Job Demands / Working Conditions

The Environmental Monitoring & Sampling Supervisor role requires a combination of technical expertise, leadership capabilities, and the ability to perform duties within highly regulated manufacturing environments.

Ability to work in classified cleanroom environments (ISO 5, ISO 7, and ISO 8 areas) and comply with gowning requirements, aseptic behaviors, and contamination control procedures.
Frequent entry into controlled manufacturing, laboratory, warehouse, utility, and support areas for oversight of sampling and environmental monitoring activities.
Ability to wear personal protective equipment (PPE), including cleanroom garments, gloves, safety glasses, respirators (when required), hair covers, beard covers, and safety footwear for extended periods.
Ability to stand, walk, climb stairs, bend, stoop, reach, and move throughout manufacturing and utility areas for prolonged periods.
Ability to lift and carry materials, sampling equipment, supplies, and monitoring devices weighing up to 25 pounds.
Capable of performing detailed visual inspections and accurately documenting observations and technical data.
Ability to work in environments with varying temperatures, humidity levels, noise conditions, and manufacturing operations.
Availability to support off-shift operations, weekends, holidays, plant shutdowns, investigations, audit activities, and emergency situations as business needs require.
Ability to respond promptly to environmental monitoring excursions, contamination events, utility failures, and quality-related investigations.
Must be capable of managing multiple priorities simultaneously while meeting strict deadlines in a fast-paced, compliance-driven environment.
Ability to analyze complex microbiological and environmental monitoring data, identify trends, assess risks, and make sound technical decisions.
Requires sustained attention to detail, strong organizational skills, and the ability to maintain accurate records in accordance with cGMP and Data Integrity requirements.
Frequent interaction with cross-functional teams including Manufacturing, Quality Assurance, Quality Control, Engineering, Validation, Facilities, Regulatory Affairs, and senior management.
Must be capable of delivering training, facilitating meetings, presenting technical information, and communicating effectively in both English and Spanish.
Ability to lead and motivate personnel, manage conflict, provide coaching, and drive continuous improvement initiatives.
May be required to support regulatory inspections, customer audits, and corporate assessments as the Subject Matter Expert (SME) for Environmental Monitoring and Sampling programs.
Ability to work under pressure while maintaining compliance, professionalism, and sound judgment in a highly regulated pharmaceutical, biotechnology, or medical device manufacturing environment.

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.

Environmental Monitoring and Sampling Supervisor

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Environmental Monitoring and Sampling Supervisor