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 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 (FSFAT/SATIQ/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.
