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Associate Validation Engineer at Amneal India

Piscataway Township, New Jersey, United States -

Full Time

Start Date

Immediate

Expiry Date

12 Aug, 26

Salary

0.0

Posted On

14 May, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Equipment Qualification, Facility Qualification, Utility Qualification, IQ/OQ/PQ Execution, cGMP Compliance, SOP Drafting, Process Validation, Cleaning Validation, Deviation Management, Technical Documentation

Industry

Pharmaceutical Manufacturing

Description

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. 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. Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.

Responsibilities

The role provides support for the qualification and re-qualification of equipment, facilities, and utilities to ensure cGMP compliance. Key tasks include executing IQ/OQ/PQ protocols, drafting SOPs, and collaborating with vendors and maintenance teams.