MSAT Engineer – Cleaning Validation
Core
Support GMP-regulated pharmaceutical and biopharmaceutical manufacturing operations by managing cleaning validation lifecycle activities, executing validation strategies, and ensuring compliance with regulatory standards.
Role type
MSAT Engineer – Cleaning Validation
Builds
Production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Domain
Life sciences manufacturing / Pharmaceutical GMP
Deliverable
dashboards & analysis
Required skills
PDE-based cleaning limits calculation, MACO calculations, risk-based validation methodologies, GMP regulations knowledge, contamination control principles, validation documentation practices, analytical troubleshooting, problem-solving
Preferred skills
Biologics manufacturing experience, sterile manufacturing experience, global regulatory expectations knowledge
Technologies
GMP regulations, contamination control principles, validation documentation practices
Responsibilities
Prepare, review, and support approval of Cleaning Risk Assessments, validation protocols, and summary reports; Develop cleaning trial protocols and support execution and process optimization; Coordinate validation execution, sampling activities, and data review; Support troubleshooting of cleaning-related issues, investigations, deviations, and CAPA activities; Provide guidance to cross-functional teams on validation strategies, execution approaches, and compliance expectations; Contribute to continuous improvement initiatives related to cleaning processes and validation practices
Seniority
Mid-level, hands-on IC
