Environmental Monitoring and Sampling Supervisor

About the role

The Environmental Monitoring and Sampling Supervisor leads the EM and utilities sampling programs across manufacturing, laboratory, warehouse and support areas. This role ensures compliance with cGMP, regulatory requirements and company procedures while maintaining a safe, controlled environment.

Key responsibilities

• Supervise and coordinate all environmental monitoring and utilities sampling activities, including viable and non‑viable sampling in cleanrooms, aseptic suites and controlled environments.
• Lead the EM team – scheduling, training, performance management and development to achieve operational excellence.
• Verify collection, documentation and review of data according to ALCOA+, data integrity and Good Documentation Practices.
• Analyze trends, investigate excursions, out‑of‑trend results and contamination events, and drive CAPA implementation.
• Maintain cleanroom classification programs, HEPA filter integrity testing and environmental qualification assessments.
• Support internal and external audits, regulatory inspections and provide technical presentations as SME.

Required profile

• Bachelor’s degree in a science or engineering discipline (or equivalent experience).
• Minimum five years of experience in pharmaceutical/parenteral manufacturing quality roles.
• At least three years of supervisory/managerial experience in the same industry.
• Fully bilingual (Spanish/English) with strong technical writing abilities.
• Ability to work in classified cleanroom environments and comply with gowning and biosafety requirements.

Required skills

• Environmental Monitoring and Utilities Sampling
• GMP / cGMP knowledge and application
• ALCOA+ and Data Integrity principles
• Good Documentation Practices (GDP)
• Cleanroom Classification, HEPA filter integrity testing
• Microbiological data analysis and trend reporting
• SOP development and technical writing