Validation Engineer I, Engineering

Found in: Talent US C2 - 2 weeks ago

Branchburg, United States Amneal Pharmaceuticals Full time

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.

Education

Bachelors Degree (BA/BS) in Pharmaceutical manufacturing, Engineering, Science or relevant field - Required

Work Experience

0-2 years of experience in Engineering, Pharmaceutical Industry, cGMP environment with Bachelor degree. - Required 1 year or more Experience in Engineering, Pharmaceutical Industry, cGMP environment with Bachelor degree. - Preferred

Skills and Abilities

Proficient in MS Office. - Advanced Excellent technical writing skills. - Intermediate Excellent oral and written communication skills. - Intermediate Must be able for follow direction and execute assigned work independently, after initial training is completed. - Intermediate Ability to work both independently and in conjunction with a team - Advanced

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