Associate Validation Engineer

Amneal Pharmaceuticals • Branchburg Township, NJ

158d

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.
• 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.
• Support process validation and cleaning validation by providing product contact surface area, equipment qualification parameter ranges and challenge tests criteria to technical service.
• Work with equipment vendors to collect equipment manual and other required documents.
• Closely work with the maintenance & facility teams to complete new equipment installation as per project requirement.
• Assist with engineering projects and perform other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Chemical Manufacturing
• Number of Employees: 5,001-10,000 employees