Validation Engineer I, Engineering - Piscataway, United States - Amneal Pharmaceuticals

Description

Job Summary

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.

Essential Functions

+ 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.

Additional Responsibilities

+ Assist with engineering projects and performs other duties as assigned.