Senior MSAT Engineer (Pharma/Biotech)

This position is responsible for ensuring the seamless transfer of biopharmaceutical processes, supporting the production of high-quality biologics in compliance with our client’s global standards and regulatory requirements.

Responsibilities:

• Lead technology transfer activities for biopharmaceutical processes, ensuring alignment with quality policies and cGMP standards.
• Collaborate with cross-functional teams, including R&D, Quality Assurance, and
• Manufacturing, to ensure successful process implementation.
• Provide technical expertise in downstream processing (especially in UFDF operation and 12L Single Use DS Freezing Bag operation), troubleshooting, and process optimization.
• Develop and execute process validation strategies, including risk assessments and validation documentation.
• Support lifecycle management activities, including process improvements and change control evaluations.
• Act as a technical liaison between global sites and local manufacturing teams to ensure alignment on process requirements.
• Ensure compliance with the client’s Safety, Health, and Environmental (SHE) standards throughout the technology transfer process.

About You:

• Bachelor’s or Master’s degree in Biotechnology, Chemical Engineering, or a related field.
• Proven experience in biopharmaceutical manufacturing, technology transfer, and process validation.
• Strong knowledge of cGMP regulations, quality systems
• Excellent problem-solving, communication, and project management skills.
• Ability to work collaboratively in a dynamic, cross-functional environment.
• Expertise in biologics in downstream processing techniques (especially in UFDF operation and DS Freezing in 12L SU Bag)
• Familiarity with analytical methods and equipment used in biopharmaceutical manufacturing.
• Experience with risk assessments
• Minimum 3 years of similar experience in biopharmaceutical manufacturing.

Duration : 12 months.

Based in Tuas.