The Aseptic Filling Engineer (Vial) will play a key role in supporting the startup of a state-of-the-art aseptic manufacturing facility with multiple production lines. Reporting to the Aseptic Filling Supervisor, Commercial DP (Vial Line), this role will serve as an end user for the filling area, including equipment, facilities, supporting systems, and utilities, in preparation for aseptic manufacturing operations. This includes supporting the development and maintenance of standard operating procedures (SOPs).
This role will ensure smooth day-to-day manufacturing floor operations, with a strong focus on the compliant execution of critical aseptic processes. Key activities include isolator preparation (cleaning and decontamination), sterilization and depyrogenation, aseptic filling, stoppering, and capping, while maintaining strict adherence to regulatory and quality standards.
Location : Tuas Biomedical Park with company transport provided islandwide.
Role & Responsibilities
- Support the installation and qualification of new manufacturing equipment, and own/oversee assigned 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 cleaning and decontamination, sterilization/depyrogentation, aseptic filling, stoppering, lyophilization, and capping.
- 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 aseptic filling rooms and ensure adherence to stringent requirements.
- Be flexible for the execution during off-hours and work in a shift rotation, if needed.
- Maintain compliance with training requirements at all times.
- Travel as necessary and be available for extended periods of overseas training.
Education
- Bachelor's degree in Pharmaceutical Sciences, Chemical Engineering, Biological Sciences or related field.
- 2- 5 years in relevant experience, preferably in drug product manufacturing.
- Direct experience in drug product manufacturing such as aseptic filling, or closely related area, is preferred.
- Strong interpersonal skills and ability to interact effectively with managers and peers
