Chennai, IND
20 hours ago
Serialization
Job Description: 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** . Cognizant is an equal opportunity employer that embraces diversity, champions equity and values inclusion. We are dedicated to nurturing a community where everyone feels heard, accepted and welcome. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other protected characteristic as outlined by federal, state or local laws.
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