- 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.
- Bachelors Degree (BA/BS) in Pharmaceutical manufacturing, Engineering, Science or relevant field - Required
- 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
- 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
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Validation Engineer I, Engineering - Branchburg, United States - Amneal Pharmaceuticals
Description
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
Additional Responsibilities
Education
Work Experience
Skills and Abilities