Associate Validation Engineer

Amneal • Piscataway Township, NJ

3d

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.

Requirements

• Compliance to cGMP and Amneal's quality requirements
• Ability to 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.
• Ability to help generate qualification report and help summarize the results.
• Ability to perform re-qualification of equipment, facility and utilities as required under supervision.
• Ability to identify deviations encountered during IQ/OQ/PQ execution and work with supervisor to implement mitigation solution.
• Ability to draft Standard Operating Procedure(SOP) for new operational equipment.
• Ability to support process validation and cleaning validation by providing product contact surface area, equipment qualification parameter ranges and challenge tests criteria to technical service.
• Ability to work with equipment vendors to collect equipment manual and other required documents.
• Ability to closely work with the maintenance & facility teams to complete new equipment installation as per project requirement.
• Ability to assist with engineering projects and performs other duties as assigned.

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
• Education Level: No Education Listed