Senior Mechanical Engineer

3 weeks ago


Chantilly, Virginia, United States Granules Full time
Job Description

As a Senior Mechanical Engineer at Granules Pharmaceuticals, you will oversee the development and production of pharmaceutical products, ensuring safety, quality, and purity requirements are met. Your responsibilities will include:

  • Calibrating and maintaining equipment to ensure optimal performance.
  • Developing and reviewing SOPs, DQs, IQs, OQs, and PQs for all process equipment.
  • Executing equipment/systems qualifications and validation protocols.
  • Supporting vendors qualification functions.
  • Providing coordination and support for all equipment/facility related change control, deviations, CAPAs, and Capital Projects.
  • Communicating cross-functionally with customers, vendors, suppliers, contractors, and management on project-related activities.

Requirements:

  • Bachelor's degree in Mechanical Engineering or Industrial Engineering, plus 3 years of experience in a similar role.
  • Strong knowledge of IQ/OQ/PQ, CAPA, API, PLC, and FDA regulations.

Job Location: Chantilly, VA. If you are interested in this position, please submit your resume to the HR department at Granules Pharmaceuticals, Inc.



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