Environmental Monitoring Supervisor - GMP & Aseptic Lead

Environmental Monitoring and Sampling Supervisor; Juncos (PR); Presencial; USD 95.000 - 130.000; Jornada completa

Descripción de la vacante

Mentor Technical Group is seeking an Environmental Monitoring & Sampling Supervisor to lead EM and utilities sampling across GMP manufacturing and support areas. You will supervise a team, ensuring cGMP compliance and data integrity while coordinating with QA, Manufacturing, and facilities.

The role requires strong leadership, knowledge of ALCOA+, GDP, and aseptic practices in classified environments, with bilingual English/Spanish communication skills. On-site work in the U.S.

Formación

• Bachelor's degree required; sciences or engineering preferred.
• 5+ years in manufacturing/quality in parenteral/pharma industry.
• 3–5 years supervisory/managerial experience in pharma.
• 2 years in GMP EM or utilities sampling preferred.

Responsabilidades

• Supervise EM and utilities sampling across manufacturing, lab, and support areas.
• Lead EM team: scheduling, performance management, training.
• Oversee viable and non-viable EM in classified areas.
• Oversee water systems, clean steam, and gases sampling programs.
• Ensure data integrity per ALCOA+, GDP; document reviews.
• Investigate EM excursions and contamination events.
• Collaborate with QA, Manufacturing, Engineering, Validation, Facilities, Microbiology.
• Maintain cleanroom classifications, certifications, and HEPA testing.
• Provide SME guidance on aseptic practices and contamination control.
• Develop and approve SOPs, work instructions, and risk assessments.

Conocimientos

Environmental Monitoring

Team Leadership

Regulatory Knowledge

cGMP

ALCOA+

GDP

Bilingual English/Spanish

Training & Development

Educación

Bachelor's Degree in Science

Associate's degree + 6 years QA experience

High School + 8 years QA experience

Descripción del empleo

Mentor Technical Group is seeking an Environmental Monitoring & Sampling Supervisor to lead EM and utilities sampling across GMP manufacturing and support areas. You will supervise a team, ensuring cGMP compliance and data integrity while coordinating with QA, Manufacturing, and facilities.

The role requires strong leadership, knowledge of ALCOA+, GDP, and aseptic practices in classified environments, with bilingual English/Spanish communication skills. On-site work in the U.S.