TG Singapore Hiring! Full Time MSAT Engineer – Cleaning Validation in - Ricebowl

MSAT Engineer – Cleaning Validation

Overview

An established organization within the life sciences manufacturing industry is seeking a skilled MSAT Engineer – Cleaning Validation to support GMP-regulated pharmaceutical and biopharmaceutical manufacturing operations.

This role will be responsible for supporting cleaning validation lifecycle activities, executing validation strategies, and collaborating with cross-functional stakeholders to ensure compliance with regulatory and quality standards.

Key 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 activities
• Coordinate validation execution, sampling activities, and data review
• Support troubleshooting of cleaning-related issues, investigations, deviations, and CAPA activities
• Collaborate with QA, Manufacturing, Engineering, and relevant stakeholders to ensure alignment with GMP and internal quality standards
• Support validation lifecycle activities related to equipment, processes, and technology transfer programs
• 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

Requirements

• Degree in Chemical Engineering, Biotechnology, Pharmaceutical Engineering, or a related field
• Experience in GMP Cleaning Validation within pharmaceutical and/or biopharmaceutical manufacturing environments
• Knowledge of PDE-based cleaning limits, MACO calculations, and risk-based validation methodologies
• Experience supporting technology transfer and validation lifecycle activities
• Understanding of GMP regulations, contamination control principles, and validation documentation practices
• Strong analytical, troubleshooting, and problem-solving skills
• Good communication and stakeholder coordination abilities
• Ability to work effectively both independently and within cross-functional teams in a dynamic manufacturing environment

Preferred Experience

• Exposure to biologics or sterile manufacturing environments would be advantageous
• Familiarity with global regulatory expectations and inspection readiness activities is a plus