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
