Lead Process Engineer, Life Science

该职位来源于猎聘

Main Duties：

• Leading client discussions within process and facility design to assist the client to achieve their goals
• Feasibility studies up to detailed engineering
• Participate in engineering project teams to design aseptic and biotech processing facilities with specific emphasis clean utility of the following: PW/WFI generation and distribution system, clean steam system and process gas system (included process compressed air, O2, N2. CO2 etc.)
• Coordinates with project managers to determine project scope, complexity and schedule for project development.
• Develops project execution plans (budget, milestones, deliverables and staffing plans) to deliver project on time, on budget and of the highest quality.
• Writes scope of work for process, utilities and manufacturing controls based on preliminary reviews with the client.
• Complete design deliverables for entire facility clean utility system including, water/gas system schematic diagrams, water and utility balances, black utility requirements and system P&IDs that include controls strategy, if appropriate.
• 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 PW/WFI generator, clean steam generator, PW/WFI distribution system, gas distribution system CIP / SIP and COP stations.
• Complete design for utilities generation and distribution systems. generate P&IDs for critical utility systems, such as WFI, purified water, clean steam and process gases.
• Ensure completion of quality specifications and performance data sheets for process equipment and instrumentation.
• Make use of and participate in development of company design tools including process simulation and smart P&IDs (AutoCAD, Plant 3D, SuperPro, etc.).
• Establish and maintain excellent working relationships with clients and members of the Exyte design team.
• Successfully interface with clients, project managers, and engineering professional and coordination between client, suppliers and sub-contractors Other Duties：
• 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 Type of Experience:
• Minimum of fifteen (15) years engineering experience and a minimum of ten (10) years in bioprocess design, preferably in the pharmaceutical and biotechnology industries.
• Experience in the life sciences (pharmaceutical, biotech, nutraceutical, etc.) is preferred.
• Sound knowledge of system design, applicable codes and cGMP’s as they affect process design and equipment specification and knowledge of pharmaceutical production
• Possesses a demonstrated ability for analytical thinking, an aptitude for structured problem solving, superior verbal and written communication skills as well as a strong work ethic.
• Must be able to build strong rapport within department and across Exyte disciplines.
• Travel may be required as projects are being executed at different parts of China.
• Knowledge of Good Manufacturing Practice (GMP)
• Knowledge of equipment design and system specifications, utility system calculations and energy optimizations
• Knowledge of 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 E3D

PDMS