Validation Engineer I, Engineering at Amneal Pharmaceuticals LLC (J0P) in Brookhaven, New York

Job Description:

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