Validation Engineer II - Manufacturing Technical Services

Description:

The Validation Engineer II 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.