Job Description:
- Contribute to Life Science projects for Antaes Asia clients
- Key participant in the Quality Review Board
- Support Manufacturing Operations in executing validation, trials, development, and technical transfer activities
- Participate in new technology and/or new process transfer
- Develop relationships within the Value Stream team and with other departments (MSAT, QA, QC TS, etc.).
- Manage high-complexity deviation investigations and CAPAs related to process or technical events.
- Oversee changes including eCCs, SMRs, and SAP master data (e.g., BOM).
- Address quality and business-continuity risks.
- Conduct gap analyses against QMS (CQMPs, GGs) and Quality Alerts.
- Identify, manage, and execute improvement initiatives in:
- Batch records/SOPs.
- Process optimization.
- Alarms management.
- Materials management.
- Operational Excellence (OE) initiatives.
- Plan, manage, and execute deliverables using proper and timely resources.
- Prepare documents and training materials for the operations department.
- Support non-process specific training.
- Explain trends and support Manufacturing Operations in tracking process parameters.
- Coordinate effective utilization of ad-hoc team members (Manufacturing Operations Staff).
- Contribute to the promotion of Antaes services on top of assistance provided to clients
Job Requirements:
- Degree in Chemical Engineering, Biotechnology, Life Sciences or a related field, or equivalent experience
- Knowledge in Biotechnology equipment and process
- Equipment and process troubleshooting skills
- Knowledge in Lean Six Sigma tools
- Knowledge in Project Management
- Adherence to safety protocols and regulatory compliance
- Candidate must be highly motivated, be able to work independently as well as in a team and have good organizational and oral and written communication skills
