Senior Validation Engineer

Amneal New Jersey•Piscataway, NJ

10h

About The Position

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.

Responsibilities

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