We are looking for an experienced MSAT Engineer - Cleaning Validation to support a biopharmaceutical manufacturing program. This role focuses on cleaning validation strategy, execution, and process optimization, ensuring compliance with GMP and regulatory standards.
This is a process science-driven role, requiring strong technical depth in cleaning validation and the ability to translate scientific principles into practical manufacturing execution.
Key Responsibilities
- Lead and own cleaning validation strategy and execution across manufacturing processes
- Design, develop, and optimize CIP (Clean-in-Place) processes
- Define acceptance criteria, sampling strategies, and validation protocols
- Ensure all cleaning processes meet GMP and regulatory compliance requirements
- Collaborate with Operations, QA, and Engineering teams for validation execution
- Support risk assessments, deviation investigations, and CAPA related to cleaning processes
- Drive continuous improvement initiatives for cleaning efficiency and effectiveness
- Support preparation and review of validation documentation (protocols, reports, risk assessments)
Requirements
- Bachelor's degree in Chemical Engineering, Biotechnology, or related field
- 5-8 years of experience in biopharmaceutical manufacturing
- Strong hands-on experience in cleaning validation (must have ownership experience)
- Proven expertise in CIP design, optimization, and process understanding
- Strong knowledge of GMP, validation lifecycle, and regulatory expectations
- Experience in risk assessment, deviation handling, and validation documentation
- Ability to translate scientific concepts into site execution
- Experience working within MSAT / Process Engineering teams
