Purpose
Performs functions associated with cGMP manufacturing operations within the biologics production facility. Uses sophisticated programs (such as LIMS, SAP, automated control systems, MES, etc.) to collect and evaluate operating data, to comply and strictly adhere to Standard Operating Procedures and Good Documentation Practices.
Responsibilities
· Learn and perform well-defined procedures within cGMP manufacturing environment.
· Perform equipment monitoring, 6S housekeeping and maintain Kanban system.
· Perform basic laboratory tasks (e.g. IPC sampling, pH/ conductivity/ osmolality measurements etc.).
· Trained & signed off on On-The-Job Training (OJTs) procedures relating to CIP/ SIP/ Bioprocessing Equipment, Holding Vessels & instrument operations.
· Demonstrate aseptic technique in handling of product/ materials.
· Perform basic process & equipment troubleshooting.
· Multi-task on equipment preparations & operations to ensure adherence to production schedule.
· Use Standard Operating Procedures (SOPs), logbooks & Electronic Batch Records (EBRs) effectively & competently.
· Submit IPC samples via Laboratory Information Management System (LIMS).
· Maintaining inventory levels.
· Equipment preparation (CIP / SIP).
· Basic knowledge in single use applications.
· Basic skill and knowledge in Fermentation cell culture and Bioreactor processing which includes set up and operation of stainless steel and/or single use vessels, inoculum aseptic techniques, vial thawing and centrifugal harvest operation.
· Basic technical knowledge of Automation Control System with DeltaV and/or PLC control parameters for bioreactor and centrifuge operation.
Qualification:
· Degree/Diploma in Science, Engineering or equivalent.
· Minimum 2 years of relevant experience working in Biologics Production facility.
· Fresh graduates are welcomed as training will be provided.
· Some relevant work experience in a similar manufacturing industry or cleanroom environment.
· Proven problem-solving skills and the ability to adapt to new requirements.
· Strong working knowledge of Microsoft and other software packages, SAP, LIMS, DeltaV, POMs are preferred.
· Knowledge of Biopharmaceutical processing is an advantage.
· Strong communication and interpersonal skills.
· Experience with cGMP documentation and record maintenance is preferred.
· Excellent attitude towards work and keen willingness to learn and perform ‘hands-on’ work.
· Excellent team player with strong troubleshooting and analytical skills.
· 12-hour rotating Shift work is required.