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Description:

The Validation Engineer is responsible for performing validation and Engineering activities, conducting development studies, analyzation and assist in improving pharmaceutical systems and processes.

Essential Functions:

+ Design, review and execute validation document activities such as Factory acceptance test (FAT), Installation qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) for equipment /utilities/facilities and generate reports which summarize results, specification and its acceptance criteria

+ Performs re-qualification of equipment, facility and utilities as required

+ Responsible for creating validation project and validation progress reports - weekly and monthly

+ Participate in evaluation of failures and out of specification results impacting compliance with quality, safety and other design requirements

+ Provide Technical Inputs and develop strategy for various domestic and international Site Transfer projects. Provide regular status updates to the department and program management.

+ Closely works with the maintenance & facility teams to complete new equipment installation, commission and validation as per project requirement.

+ Performs engineering assessment and writes investigation reports for non-conformance

Additional Responsibilities:

+ Assists with engineering projects and performs other duties as assigned.