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:

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

About You:

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

Duration: 12 months.

Based in Tuas.