Environmental Monitoring & Utilities Supervisor (GMP)

Mentor Technical Group; Caguas, Boston (PR, MA); Híbrido; USD 90.000 - 120.000; Jornada completa

Descripción de la vacante

Mentor Technical Group seeks an experienced Environmental Monitoring Supervisor to lead EM and utilities sampling across classified manufacturing and cleanrooms. You will supervise a team, manage scheduling and training, and ensure data integrity per ALCOA+ and GDP.

You will collaborate with QA, Manufacturing, Engineering, and Facilities to implement CAPAs and maintain regulatory compliance. The role requires strong leadership, regulatory knowledge (FDA/EMEA/cGMP), and bilingual English/Spanish

Formación

• Five (5) years of experience in a manufacturing operation or quality role in Parenteral or Pharmaceutical Industry.
• Three (3) to five (5) years in a supervisory/managerial position in Parenteral or Pharmaceutical Industry.
• Two (2) years of GMP Environmental Monitoring or Utilities Sampling experience preferred (clean room env., aseptic).
• Proven knowledge of Parenteral/pharmaceutical environmental monitoring programs, aseptic operations, isolators, sanitization and sterilization.
• Must have knowledge of FDA, EMEA compendium requirements, cGMP, GLP, and FDA regulations; ability to interpret/apply.
• Fully bilingual English/Spanish with strong writing skills.

Responsabilidades

• Supervise, coordinate, and oversee EM and utilities sampling to ensure cGMP compliance.
• Lead Environmental Monitoring team: scheduling, performance management, training, and development.
• Ensure execution of viable/non-viable EM in classified manufacturing and cleanroom areas.
• Oversee utilities sampling programs (WFI, PW, clean steam, gases).
• Verify data collection, documentation, review, and approval per ALCOA+ and GDP.
• Review trends, sampling results and microbiological data to identify risks and shifts.
• Lead investigations of excursions, exceedances, and deviations; implement CAPAs.
• Collaborate with QA, Manufacturing, Engineering, Validation, Facilities, Microbiology to assess impact and corrective actions.
• Maintain cleanroom classification programs, certifications, airflow studies, HEPA testing, and qualification assessments.
• Provide SME input on aseptic practices, contamination control, sterilization, sanitization and microbiological controls.
• Develop, revise, review SOPs, work instructions, protocols, risk assessments, and technical reports.
• Ensure personnel qualification programs including aseptic gowning and contamination control.
• Monitor KPIs related to compliance, investigations, sampling, data review, and training.
• Support audits/inspections with documentation and technical responses.
• Ensure compliance with client SOPs, GMPs, and regulatory requirements.
• Review and approve EM trend reports, utility monitoring, and annual product quality review inputs.
• Drive continuous improvement in sampling efficiency and contamination control.
• Coordinate EM activities during shutdowns, maintenance, and commissioning.
• Manage department resources and budget to support operations.
• Ensure safety, biosafety, and health standards compliance.
• Serve as SME for EM and Utilities sampling during inspections and audits.

Conocimientos

Leadership

Bilingual English/Spanish

cGMP knowledge

Regulatory compliance

Data integrity

Training & development

Root cause analysis

Cross-functional collaboration

Documentation

Educación

Bachelor's degree in sciences

Associate degree + 6 years experience

High school diploma + 8 years experience

Descripción del empleo

Mentor Technical Group seeks an experienced Environmental Monitoring Supervisor to lead EM and utilities sampling across classified manufacturing and cleanrooms. You will supervise a team, manage scheduling and training, and ensure data integrity per ALCOA+ and GDP.

You will collaborate with QA, Manufacturing, Engineering, and Facilities to implement CAPAs and maintain regulatory compliance. The role requires strong leadership, regulatory knowledge (FDA/EMEA/cGMP), and bilingual English/Spanish