VALIDATION ENGINEER I, ENGINEERING
: Job Details :

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.