Role & Responsibilities :
- Support installation and qualification of new manufacturing equipment; own and oversee assigned equipment packages.
- Assist in developing and implementing operational procedures, including SOPs, master batch records, and work instructions.
- Ensure compliance with quality standards and client requirements for aseptic processes such as cleaning, sterilization/depyrogenation, aseptic filling, stoppering, lyophilization, and capping.
- Collaborate with Engineering, Maintenance, and Validation teams to ensure timely calibration and validation of production equipment.
- Stay current with global regulatory requirements (FDA, EMA, PIC/S, ICH) and cGMP standards for aseptic manufacturing and product introduction.
- Maintain aseptic filling rooms and ensure strict adherence to cleanroom requirements.
- Be flexible to support off-hour execution and shift rotations when required.
- Maintain compliance with all training requirements.
- Travel as needed, including extended periods for overseas training.
- Working Location : Tuas West Biomedical Park with company transport provided islandwide
Requirement :
- Bachelor’s degree in Pharmaceutical Sciences, Chemical Engineering, Biological Sciences, or a related field.
- Minimum 2 - 5 years of relevant experience in drug product manufacturing
- Hands-on experience in aseptic filling or related drug product manufacturing processes preferred.
- Strong interpersonal skills with the ability to work effectively across teams.
