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.

Education:

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

Experience:

• 1 year or more in 1 year experience in Engineering, Pharmaceutical Industry, cGMP environment w/Bachelors

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