Responsibilities :

• Act as key interface between Global Automation & Integrated Services (GAIS) technical team and design firms on design actions and technical standards
• Support new facility design and validation for AIS systems (DCS, PLC / Delta V Systems).
• Lead activities such as URS review to ensure all design consideration and technical requirement for integration are incorporated into the design.
• Lead activities such as drafting and/or review design and commissioning documents (FS、FAT/SAT、IQ/OQ protocols etc) to ensure requirements are in place and validated.
• Involve & in key system FATs and ensure the integration design and successfully tested.
• Lead & coordinate the AIS discipline activities on site installation, commissioning and qualifications as per project plan and timeline. This includes management of System Integrators (SIs) and other system suppliers.
• Lead/explore initiatives on new technology applications to projects to boost productivity and compliance.
• Act Acts as project lead leading a team post project to support routine manufacturing activities for both clinical and commercial Drug Substance (DS) & Drug Product (DP) processes with focus on performance improvement for AIS systems.
• Act as SME to support external and internal audits and follow up audit actions related to AIS discipline.
• Initiate continuous improvement activities and implementing change control process to continuously improve the process and meet the customer and regulatory requirements.
• Leading/Supporting other overseas AIS projects as needed for WuXi Biologics.

Requirement :

• Degree in Chemical Engineering, General Engineering, Biochemistry, Automation, or Electrical & Instrumentation.
• Min 10 years of relevant experiences in the pharmaceutical or biologics industry.
• Hands-on experience with biologics drug manufacturing processes and familiarity with key VPE equipment in drug substance or drug product facilities.
• Proficiency with at least one major PLC brand and strong understanding of integration strategies, including deployment experience aligned with GAMP5 validation principles.
• Solid knowledge of DCS systems and concepts, with practical experience in at least one major DCS platform (e.g., DeltaV).
• Strong collaboration, coordination, and interpersonal skills to work effectively across departments and with multi-disciplinary teams.
• Ability to support overseas projects and adapt to different cultures and working practices.
• Good understanding of GMP regulations and compliance requirements.
• Effective communication skills to collaborate across regions and time zones.