Senior / Principal Automation Engineer (DeltaV / PLC/DSC System)
WUXI BIOLOGICS BIOPHARMACEUTICALS SINGAPORE PRIVATE LIMITED
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.