MSAT Environmental Monitoring (EM) Expert

We are seeking a MSAT expert in Environmental Monitoring (EM) to lead Environmental Monitoring Performance Qualification (EM PQ) for our biotechnology operations. This role ensures compliance with GMP, ISO 13485, and 21 CFR 820 standards while driving cross-functional collaboration in a regulated manufacturing environment.

This is a hybrid position (2 days on-site, 3 days remote).

Key Responsibilities

Technical Leadership & Validation

• Lead EM Performance Qualification (PQ , ensuring adherence to protocols, scientific rigor, and regulatory compliance
• Execute validation tasks, including protocol development, testing, and reportin g, while maintaining alignment with GMP, ISO 13485, and 21 CFR 820
• Provide exhaustive project planning, budget evaluation , and risk management for validation activities.

Regulatory Compliance & Quality Assurance