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Posted 110 months ago

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Validation Engineer

Kenilworth, NJ, United StatesRemoteFull-time

AI Summary

A Validation Engineer executes validation activities across project lifecycles, ensuring compliance with FDA GAMP 5 and related standards for pharmaceutical solutions.

About this role

Validation Engineer

Thanks & Regards

Rajesh
KRG Technologies, Inc.,

661 558 8000 Ext :514




Job Description :

• Experience on V-Life cycle of project execution methodology

• Aware of FDA compliance on GAMP 5 standards

• Worked on Standards like ISA 95, ISA 88, B2MML, PackML etc.

• Handled the protocols like DeviceNet, HART, Modbus, ProfiBus, FieldBus, OPC UA, OPC DA, TIBCO, RFI, etc

• Handled LIMS implementation E.g. StarLIMS

• Handled OSI PI packages like IP.21; ACE

• Certified on GAMP standards

• Faced any pharmaceutical solution audit (FDA)

Additional Information

All your information will be kept confidential according to EEO guidelines.

Skills

ACEB2MMLDeviceNetFDA ComplianceFieldbusGAMP 5HARTIP.21ISA-88ISA-95LIMSModbusOPC-DAOPC UAOSI PIPackMLProfibusRFISTARLIMSTibco

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