Senior Validation Engineer

Amneal • 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed
• Number of Employees: 5,001-10,000 employees