Senior Mechanical Engineer

4 weeks ago


Chantilly, Virginia, United States Granules Pharmaceuticals Full time
Job Summary

Granules Pharmaceuticals is seeking a highly skilled Senior Mechanical Engineer to oversee the calibration and validation of equipment used in the development and production of pharmaceutical products. The ideal candidate will have a strong background in mechanical engineering and experience in ensuring safety, quality, and purity requirements are met.

Key Responsibilities
  • Oversee the development and execution of qualification documentation to support the System Life Cycle, including facilities, utilities, equipment, and automation.
  • Ensure equipment is suitable for its intended use and develop and review SOPs, DQs, IQs, OQs, and PQs.
  • Execute equipment/systems qualifications and validation protocols and support vendors qualification functions.
  • Provide coordination and support for all equipment/facility related change control, deviations, CAPAs, and Capital Projects.
  • Communicate cross-functionally and 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.
What We Offer

Granules Pharmaceuticals offers a competitive salary and benefits package, as well as opportunities for professional growth and development.



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