Senior Process Engineer

Job Description:

The core focus of the role is to develop Concept Design, Basic Design, and Detail Design Package; to support project daily design work, including but not limited to Develop the Design Packages, daily Design Coordination, Design Management, Communicate with WuXi Biologics Internal and/or External Ender Users / Design Firm / Consultant, Project Professional Consultants, and etc.

To work on multi-projects mode, with full-time or part-time arrangements according to project requirements.

Key Roles and Responsibilities:

1． Lead design, build, commissioning and qualification of manufacturing facilities and process system/equipment of biopharmaceutical therapeutics. Act as the design manager in the project organization.

2． Establish technical support initiatives for GMP operations in a multi-product cell culture and purification facility

3． Network with Manufacturing and Quality organizations to establish a reliable state of process control. Maintain process knowledge and ownership

4． Lead the proposal, initiation, testing and implementation of changes to DS/DP project

5． Develop advanced process monitoring programs using a variety of data analysis methods and techniques including multivariate methods

6． Develop technical strategies and lead studies to provide a science-based approach for the resolution of deviations, investigations and process issues

7． Establish continuous improvement strategies and participate in cross-functional initiatives

8． Develop documents (technical memos, protocols, reports, etc.) related to process monitoring programs, studies, annual product reviews and non-conformances

9． Act as an SME and design manager role to support the design, construction, commissioning, qualification and operation of GMP MBP SS system of WuXi Biologics

10． Attend Design related Meetings, Organize and Lead Design related Meetings if required

11． Proactively coordinate with WuXi Biologics for Engineering, Engineering Management, and etc., and all relevant Design Firm / Consultants, Project Professional Consultants, Project Management Consultants and etc.

12． Enable to travel or relo to the project site in China or oversea per demands

Key Skills Required:

1． Familiar with the biologics process (DS/DP) simulation/calculation.

2． Familiar with the SS buffer/media prep system design. Enable to develop the PFD/P&ID according the process input.

3． Must have the relevant professional qualification in own discipline, at least Bachelor Degree

4． At least 15 Years Work Experience in relevant discipline as General Role, and at least 8 Years Work Experience in relevant discipline as Senior Role.

5． Must have general Design and Design Management Knowledge

6． Must have previous experience of Oversea and/or at least Local International Pharmaceutical, Biological Project for Conceptual Design, Basic Design, Detail Design, Service During Construction

7． Proficient in use of AutoCAD, Naviswork, 3D Skill such as Revit is preferred

8． Must familiar in Reviewing and Written of Specification

9． Must in Proficient in Spoken and Written English, Oversea Work Experience is preferred

10． Must be Proactive, Determination, Self-motivated, have Ownership, and Strong Anti-pressure Capability