Mechanical Engineer Leader

1 week ago


Chantilly, Virginia, United States Granules Full time
About the Role

As a Sr. Mechanical Engineer with Granules Pharmaceuticals, Inc., you will play a pivotal role in ensuring the safety, quality, and purity of our pharmaceutical products. This position is based in Chantilly, VA.

Key Responsibilities
  • Oversee the development and production of pharmaceutical equipment, ensuring compliance with government regulations, including FDA (21 CFR 210/211 and Part 11), EMA, and company policies.
  • Lead the evaluation, maintenance, and calibration of equipment, as well as the development and execution of qualification documentation to support the System Life Cycle.
  • Coordinate with cross-functional teams, including manufacturing, formulation development, packaging, and Quality assurance personnel, to ensure seamless project execution.
  • Develop and review SOPs, DQs, IQs, OQs, and PQs, as well as change controls for all process equipment.
  • Supervise 2 Mechanical Technicians and provide guidance on equipment/systems qualifications and validation protocols.
Requirements
  • A Bachelor's degree in Mechanical Engineering or Industrial Engineering, plus 3 years of experience in a related field or as a Sr. Technical Service Engineer.
  • An alternative to a Bachelor's degree is an Associate's Degree plus 2 years of experience.
  • Strong skills and working knowledge of IQ/OQ/PQ, CAPA, API, PLC, FDA regulations, cGMP/SOPs.


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