Summary:
Senior DeltaV Automation Engineer is responsible to work with the global/local team to review the design, involve in the commissioning & qualification activities of DeltaV to control Drug Substance (DS) Process Equipment (Stainless Steel System, Bioreactor, Centrifuge etc.). 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:
- Work with Global Automation Team (GAIS) to design and develop a DeltaV Platform to control Drug Substance Process Equipment including Stainless Steel System (SSS), Upstream/Downstream Vendor Provided Equipment (VPE) equipment.
- Prepare/Review URS, FS, Design Document with GAIS and Emerson. Ensure the design can meet the requirements and standards.
- Participate in the DeltaV FAT/Integrated FAT with SSS, follow up with punches and make sure all open items are resolved before system is delivered to the site.
- Work with cross-functional team to supervise the equipment/system installation, support the commissioning and qualification activities.
- Support Global Automation Team to integrate VPE into DeltaV.
- Support routine manufacturing activities in terms of troubleshooting and improving for DS Process.
- Be responsible for the periodic/preventive maintenance of DeltaV system, including data backup, account management, time calibration, etc.
- Develop and implement standard operating procedures (SOPs) for DeltaV system.
- 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 DeltaV (both hardware and software) and good working knowledge on its integration strategy with related deployment experience following GAMP5 validation approach.
- 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.