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