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Validation Engineer I, Engineering

2 months ago

Shirley, New York, United States Amneal Pharmaceuticals of New York LLC Full time
Job Summary

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.
  • Collaborate with equipment vendors to collect equipment manuals and other required documents.
  • Work closely with the maintenance and facility teams to complete new equipment installations as per project requirements.
Additional Responsibilities
  • Assist with engineering projects and perform other duties as assigned.
Requirements
  • 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).
Skills and Abilities
  • 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.
Equal Opportunity Employer

Amneal Pharmaceuticals of New York LLC is an equal opportunity employer and welcomes applications from diverse candidates.