Validation Engineer I, Engineering
5 days ago
The Validation Engineer I plays a crucial role in ensuring the quality and compliance of Amneal Pharmaceuticals of New York LLC's equipment, facilities, and utilities. This position requires a strong understanding of cGMP regulations and quality requirements.
Key Responsibilities- Assist in the preparation and execution of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for equipment, facilities, and utilities.
- Help generate qualification reports and summarize results for review by the supervisor.
- Perform re-qualification of equipment, facilities, and utilities as required under supervision.
- Identify deviations encountered during IQ/OQ/PQ execution and work with the supervisor to implement mitigation solutions.
- Draft Standard Operating Procedures (SOPs) for new operational equipment.
- Support process validation and cleaning validation by providing product contact surface area, equipment qualification parameter ranges, and challenge tests criteria to technical services.
- Work with equipment vendors to collect equipment manuals and other required documents.
- Closely collaborate with the maintenance and facility teams to complete new equipment installations as per project requirements.
- Assist with engineering projects and perform other duties as assigned.
- Bachelor's Degree in Pharmaceutical manufacturing, Engineering, Science, or a relevant field.
- 0-2 years of experience in Engineering, Pharmaceutical Industry, cGMP environment with a Bachelor's degree.
- 1 year or more of experience in Engineering, Pharmaceutical Industry, cGMP environment with a Bachelor's degree (preferred).
- Proficient in MS Office.
- Excellent technical writing skills.
- Excellent oral and written communication skills.
- Ability to follow direction and execute assigned work independently after initial training is completed.
- Ability to work both independently and in conjunction with a team.
Amneal Pharmaceuticals of New York LLC is an Equal Opportunity Employer.
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Shirley, New York, United States Amneal Pharmaceuticals of New York LLC Full timeJob SummaryThe Validation Engineer I plays a crucial role in ensuring the quality and compliance of Amneal Pharmaceuticals of New York LLC's equipment, facilities, and utilities. This position requires a strong understanding of cGMP regulations and quality requirements.Key ResponsibilitiesAssist in the preparation and execution of Installation Qualification...
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