Associate Validation Engineer

Role 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.

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
• 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.

Qualifications

• Education: Bachelors Degree (BA/BS) Degree in Pharmaceutical manufacturing, Engineering, Science or relevant field - Required
• Experience: 0-2 years of experience in Engineering, Pharmaceutical Industry, cGMP environment with Bachelor's degree. 1 year or more in Experience in Engineering, Pharmaceutical Industry, cGMP environment without Bachelor's degree.

Skills

• 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

Education

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

Additional Requirements

• This position requires successful completion of an OSHA-compliant Respirator Fit Test.