Associate Validation Engineer 1st Shift 8:30am-5:00pm

Amneal Pharmaceuticals, Inc. • Brookhaven, NY

26d • Onsite

About The Position

The Validation Engineer I provides support in performing equipment, facility and utility qualification activity and re-qualification activity to ensure compliance to cGMP and Amneal's quality requirements.

Responsibilities

• Assist in the preparation/ execution of Installation Qualification(IQ)/Operational Qualification(OQ)/ Performance Qualification(PQ) protocols for equipment, facility and utilities as well as related software.
• Help generate qualification report and help summarize the results which will be reviewed by the supervisor
• Performs re-qualification of equipment, facility and utilities as required under supervision
• Identify deviations encountered during IQ/OQ/PQ execution and work with supervisor to implement mitigation solution
• Draft Standard Operating Procedure(SOP) for new operational equipment
• Supports process validation and cleaning validation by providing product contact surface area, equipment qualification parameter ranges and challenge tests criteria to technical service
• Works with equipment vendors to collect equipment manual and other required documents
• Closely works with the maintenance & facility teams to complete new equipment installation as per project requirement.
• Assist with engineering projects and performs other duties as assigned.

What This Job Offers

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