Summary:
Senior Utility Automation Engineer is responsible to work with the global/local team to review, design and implement the automation systems for utility (CU & BU) equipment using Siemens PLC/HMI/SCADA in both utility and production areas during the project stage. Prepare for the operational readiness and provide system administration and maintenance oversight of the automation systems. Ensure the availability of the systems to the end-user.
Job Responsibilities:
- Act as automation SME to review the design of Utility Vendor Provided Equipment (VPE) including but not limited to WFI, Purified Water, Pure Steam, Black Utilities etc.
- Support new facility design and validation with focus on integration of utility VPE into mainframe control systems (DCS, BMS, CU SCADA and OT).
- Review URS for utility VPEs to ensure all design consideration and technical requirement for integration are incorporated into the design.
- Draft and/or review design and commissioning/qualification documents (FS, DS, FAT/SAT, IQ/OQ protocols etc.) to ensure utility VPE can meet the user requirement/standards.
- Participate in the FAT, follow up with punches and make sure automation related items are resolved before system is delivered to the site.
- Coordinate the AIS discipline activities on site installation, commission and qualifications. This includes management of System Integrators (SIs) and VPE suppliers.
- Act as utility VPE SME to troubleshoot and improve the system.
- Act as system owner to deploy a CU SCADA system together with Global Automation.
- Be responsible for the periodic/preventive maintenance of automatic control system (CU SCADA, PLC, HMI etc.) of utility equipment, including data backup, account management, time calibration, etc.
- Develop and implement standard operating procedures (SOPs) for the utility automation systems.
- Act as utility VPE 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.
- On-call support to ensure the production continuity
- Job grade offered will be based on candidate's experience and qualifications.
Qualification:
- Bachelor or Diploma degree in Chemical/Biochemical Engineering, Generic Engineering, Biochemistry, Automation, Electrical& Instrument
- For Bachelor's degree, Minimum 3 years of relevant experience in pharmaceutical/biological industry
- For Diploma's degree, Minimum 5 years of relevant experience in pharmaceutical/biological industry
- Familiar with at least one major brand PLC and good working knowledge on its integration strategy with related deployment experience following GAMP5 validation approach. Siemens PLC/HMI, WinCC experience is preferred.
- Familiar with different communication protocols.
- Knowledge about OT infrastructure in production plants is preferred.
- Strong customer service, coordination, and interpersonal skills. Able to work cross-department and work with multi-discipline to drive project to success.
- Good knowledge on GMP, 21 CFR Part 11 and EU Annex11 regulation and requirement.
- Able to communicate and work across different regions and different time zones.
- Self-motivated, quick paced with flexibility to meet aggressive timeline.
