Validation Engineer I, Engineering

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

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.