Job 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.
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.
Assist with engineering projects and performs other duties as assigned.
Qualifications
Bachelors Degree (BA/BS): Degree in Pharmaceutical manufacturing, Engineering, Science or relevant field.
0-2 years of experience in Engineering, Pharmaceutical Industry, cGMP environment with Bachelor degree.
Skill/Ability
Proficient in MS Office - Advanced
E xperience with Valgenesis, Blue Mountain or similar software - Preferred
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
About Us
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.
