Job Information
Amneal Pharmaceuticals of New York LLC Validation Engineer I, Engineering in Brookhaven, New York
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 moreExperience 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
Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity
Minimum Salary: 0.00 Maximum Salary: 0.00 Salary Unit: Yearly