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Description:

The Validation Engineer III performs validation and engineering activities; conducts development studies; and monitors, analyzes and assists in improving pharmaceutical systems and processes. Provides detailed reports to management.

Essential Functions:

+ Design, develop and execute validation documents, define validation strategy.

+ 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

+ Prepare and review various documents using QUMAS software.Provides technical expertise for investigation and resolution of process deviations, development and interpretation of data trending, initiation and review of change controls.

+ Develops User Requirements Specification (URS) and Design Specifications.

+ Oversee the collection of equipment manuals from vendors and other required documents as well as Factory Acceptance Test (FAT) execution.

+ Design and develop test strategy and methodology for the validation of complex equipment.

+ Manage GMP documentation by supporting cGMP programs including: Risk Analysis, Change Control, and Standard Operating Procedure and Notice of Investigation (NOI)/Corrective Action and Preventative Action (CAPA).

+ Partner with management, technical peers, and negotiate with vendors to gain consensus on design, testing and methodology.

+ Develops/updates operational and engineering related standard operating procedures to comply with cGMP and regulatory requirements.

Additional Responsibilities:

+ Assist with Engineering projects as needed. Supervise and train staff as needed. Perform other duties as assigned.