Associate Validation Engineer
AmnealNew York, United States
Posted April 2, 2026
Full Time
About the Company
Amneal is a dynamic pharmaceutical company focused on delivering affordable access to essential medicines. With a robust generics business and growing portfolios in injectables, biosimilars, and international markets, Amneal invests in scientific rigor, production capabilities, and employee well-being to enhance its value proposition.
Job Description
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.
Requirements
- 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.
- Perform 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.
