Summary:
Senior Process Automation Engineer is responsible to work with the global/local team to review the design, involve in the commissioning & qualification activities of Process Equipment. 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 Process Vendor Provided Equipment (VPE) including but not limited to Vial Filling Line, PFS Filling Line, Freeze Dryer, Autoclave, Parts Washer etc.
- Review URS for 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 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.
- Work with cross-functional team to supervise the equipment installation, support the commissioning and qualification activities.
- Support Global Automation Team to integrate Vendor Provided Equipment (VPE) into mainframe control systems/network (DCS, BMS and OT).
- Act as VPE SME to support routine manufacturing activities to troubleshoot or improve the system for both clinical and commercial Drug Substance (DS) & Drug Product (DP) processes.
- Be responsible for the periodic/preventive maintenance of automatic control system (SCADA, PLC, HMI, DCS, etc.) of process equipment, including data backup, account management, time calibration, etc.
- Develop and implement standard operating procedures (SOPs) for the automation systems.
- Act as 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
- Deep knowledge of at least one major brand PLC/SCADA and good working knowledge on its integration strategy with related deployment experience following GAMP5 validation approach. Siemens PLC, AVEVA InTouch experience is preferred.
- Familiar with different communication protocols.
- Knowledge about Servo and VFD.
- 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.
