Job Summary (ISG) : Serialization Engineer
Overview
Candidate with a strong background in automation engineering with a focus on Systech / Antares systems. Experience with Vision systems, Antares systems (GTS/MTS/STS/CTS) or Systech (Sentri/Advisor/Guardian).
Mandatory skills
• Proven experience on Antares systems (GTS/MTS/STS/CTS) or Systech (Sentri/Advisor/Guardian) Serialization Solution will be required.
• Strong experience in Antares/Systech Vision Level 2 (line and multiline level serialization) product deployment and support for Pharmaceutical packaging lines ( or similar product like Optel/Jekson/ Ulhman)
• Business process knowledge -Pharmaceutical products packaging hierarchy, aggregation, Barcode printing and verification(Datamatrix, OCR, OCV, 1D Code).
• Experience in Pharma Packing Lines Like Blister machine, cartoner machine and Vision system.
• Good understanding of 21 CFR Part 11 Compliance & understanding of GMP/GAMP
• Understanding of integration of line level system with Enterprises level serialization system (like SAP ATTP/ trace link/ Systech/Antares etc.)
• Good Understanding of working and interface of the Devices like printer(Videojet/zebra/Intermec), scanner.
• Experience in Serialization and Global Track & Trace (Traceability) Strategy and Functional understanding of Pharmaceutical product sterilization concept/ process (line level- multiline level)
• Good understanding of serialization system interfaced with SAP ATTP and MES.
• Support IT process around serialization in area of quality process and supply chain.
• Basic understanding of Pharma regulatory like USFDA, EMVO etc.
• Knowledge of Uhlmann and IMA Giant Packing line will be added advantage.
• Knowledge of open protocol for data exchange like Matrikon OPC will be added advantage.
• Collaborate with cross-functional teams and assists with troubleshooting to efficiently resolve manufacturing problems.
• Maintain and Troubleshoot automated systems to ensure continuous operation.
• Document and Train staff on new automation processes and systems.
• Foster a continuous improvement mindset to optimize processes and systems.
Required Qualifications
• Bachelor's degree in Engineering or Equivalent or a related field.
• Experience in automation engineering.
• Extensive experience with Systech /Antares systems is essential.
• Understanding of Pharmaceutical Packaging line hardware, camera and label printing devi es
Experience of vision inspection systems used in packaging.
• knowledge of pharmaceutical validation concepts.
• Familiarity with formal Change Management and Incident Management Processes
• Strong understanding of PLCs, HMIs, SCADA, and other automation technologies.
• Experience with Vision systems is highly recommended.
Responsibility
• Provide first and second-line support for Antares serialization applications.
• Troubleshoot and resolve application issues reported by users. Resolving Incident/ problems • within SLA (response time/ resolution time)
• Monitor application performance and ensure efficient functionality.
• Communicate with users to understand and resolve issues promptly. Verbal and written communication with end users/ IT stake holders in process of finding resolution
• Document all support activities and solutions in the ticketing system.
• Escalate complex issues to third-line support or development teams.
• Collaborate with the development team to identify and resolve bugs. Estimating and implementing changes (proactive/ reactive) to permanently fix the incident or as a planned change
• Conduct routine checks and maintenance of the serialization applications.
• Ensure compliance with all serialization regulations and standards.
• System validation as per Quality process and SoPs
• System/ application administration activity (periodic maintenance, process compliance e.g. GMP audit, security administration, capacity planning etc.)
· Able to pick up Cross-Trainings and willing to learn other OT applications.
· Write, review and update KBA Documents for the Support Team.
· Perform periodic monitoring and qualification testing on new / existing systems according site procedures.
· Ability to work independently and prioritise tasks.
· Availability to work outside office hours when the need arises.
· Available to work in rotational shifts including night, morning and weekend shift.