Formulation / Solution Preparation Engineer, Drug Product Operations

The Formulation Engineer will play a critical role in supporting the startup of a state-of-the-art aseptic manufacturing facility with multiple production lines. Reporting to the Formulation Supervisor of Commercial Drug Product (DP), this position will serve as an end-user for Thawing and Formulation area, including its equipment, facility, supporting systems, and utilities, in preparation for aseptic manufacturing operations.

You will be responsible for the equipment and procedural readiness to ensure efficient and compliant execution of the required process steps. These include thawing and formulation in preparation for aseptic filling, and additional responsibility may be required during the initial site startup, while maintaining strict adherence to regulatory standards.

Location : Tuas Biomedical Park with shuttle bus provided islandwide

Role & Responsibilities

• Support the installation and qualification of new manufacturing equipment, and own/oversee key equipment packages.
• Support the development and implementation of operational procedures, including SOPs, master batch records, and work instructions.
• Ensure adherence to quality standards and client requirements for aseptic processes such as thawing and formulation and other processing steps as required during the initial site startup.
• Collaborate with Engineering, Maintenance, and Validation to ensure timely calibration and validation of production equipment.
• Stay informed on global regulatory requirements (FDA, EMA, PIC/S, ICH) for aseptic manufacturing and product introduction, and remain up to date on current Good Manufacturing Practices (cGMP).
• Maintain thawing and formulation rooms and ensure adherence to stringent requirements, with flexibility for the execution during off-hours.
• Travel as necessary and be available for extended period of overseas training.

Requirement :

• Bachelor's degree in Pharmaceutical Sciences, Chemical Engineering, Biological Sciences or related field.
• 2-4 years of relevant working experience in formulation process within biopharmaceutical working environment
• Direct experience in drug product manufacturing such as thawing and formulation, or closely related area, is required.
• Overseas Training Programme is required.
• Strong interpersonal skills and ability to interact effectively with managers and peers