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.