Manufacturing Support Biotechnologist - #1108214

Component Support Operator / Biotechnologist

Department: Manufacturing Support

Work Location: Tuas Biomedical Park

Responsibilities:

• Attend daily shift handover and staff meetings and work closely with teammates, various stakeholders and external vendors.

• Perform components cleaning using parts washer and manual components cleaning by following standard operating procedures for drug substance manufacturing in GMP cleanroom environment.

• Perform preparation of assemblies and autoclave activities by following standard operating procedures for drug substance manufacturing in GMP cleanroom environment.

• Draft/Author and provide inputs in documentations such as user requirement specifications, standard operating procedures and batch records etc.

• Support commissioning and validation activities, coordinate with various departments to keep track on the commissioning and operational progression to ensure project milestones are met.

• Perform and lead root-cause analysis for deviations and investigations using problem solving tools such as fish-bone diagram etc.

• Complete production batch records timely and accurately according to Wuxi XDC good documentation practice.

• Complete all relevant GMP trainings before start of GMP operations.

• Follow company EHS policy and maintain a safe work environment for everyone.

• Complete daily assigned tasks on time with minimum supervision and inform any production issues to supervisor.

• Perform routine 5S housekeeping and ensure the shopfloor is clean and tidy.

• Suggest continuous improvement initiatives to increase production efficiency and quality.

Qualifications:

• Diploma or Bachelor’s degree in life sciences and engineering discipline. (Biological/Pharmaceutical Science/Chemical Engineering/Life Science/Chemistry) with 2 to 5 years relevant experience

• Plant Start-Up or commissioning, and operational experience in biologics/vaccines will be an advantage

• Knowledge/Experience of current Good Manufacturing Practices and Good Documentation Practices applicable to Material Preparation Processes such as Parts Washer Cleaning and Autoclave Operations is desirable

• Well organised and detail-oriented, eager to learn and able to work effectively with various stakeholders in a team environment.

• Good Team player with good working ethics, takes initiative, integrity and have the positive drive.

• Good communication skills and writing skills

• Experience with Problem Solving Skills

• Able to work in the cleanroom environment