Validation Engineer

Amneal

7d

About The Position

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

Requirements

• Bachelors Degree (BA/BS) BS: in Pharmaceutical manufacturing, Engineering, Science or relevant field - Required
• 2 years or more in 2-5 years experience in engineering, pharmaceutical industry, cGMP environment
• Read, understand and verify piping & instrument diagram, engineering layout, drawing and documents

Responsibilities

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

Benefits

• health and insurance benefits
• 401(k) matching contribution
• employee well-being programs

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees