Main Duties:
- Participate in engineering project teams to design aseptic and biotech processing facilities with specific emphasis in one or more of the following: upstream/downstream processing, formulation, washing, filling, capping, sterilization, CIP/SIP, and packaging
- Feasibility studies up to detailed engineering
- Perform specification and design, installation, start-up and commissioning; turnover of documentation, and validation activities
- Process evaluation and optimization
- Development of URS, technical specifications, request for quotation, technical analysis and commercial evaluation of offers, follow-up of construction, pre-operational testing, installation commissioning and validation
- Experience in design through qualification of Fermentors, Bioreactors, CIP / SIP and COP stations, fixed & mobile process vessels, disposable bioreactors and devices
- Experience in Clean Utility, CS, PTW, WFI, Clean gasses, Equipment and system specifications, consumption calculations, energy optimizations
- Successfully interface with clients, project managers, and engineering professional and coordination between client, suppliers and sub-contractors
- cGMP/TGA/ISO 9000/EHS internal audits
- Define and review validation , qualification and GMP complains related regulations , code and standards ( CFDA and international GMP shall be considered )
- Coordinate with design team for DQ review and design GMP upgrade
- Other tasks assigned by Department manager
Requirements:
- Bachelor’s Degree : Chemical Engineering / Chemistry / Bio-medical Engineering
- 15 years related experiences
- Sound knowledge of pharmaceutical production
- Knowledge of Good Manufacturing Practice (GMP)
- Equipment design and system specifications
- Utility system calculations and energy optimizations
- Installation, start-up and commissioning; handover of documentation activities
- Proficiency in spoken and written Chinse and English.
- Diligence to solve problems and finish the work in a structured manner
- Global mindset and enjoy working in a multi-cultural environment
- Result-oriented and have a well-structured approach to your work
- You have a personal drive and are passionate about your work