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Senior Mechanical Engineer

2 months ago

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

We are seeking a highly skilled Sr. Mechanical Engineer to join our team at Granules Pharmaceuticals, Inc. in Chantilly, VA.

Key Responsibilities
  • Oversee the evaluation, maintenance, and calibration of equipment and procedures used in pharmaceutical product development and production.
  • Ensure safety, quality, and purity requirements are met by developing and executing qualification documentation.
  • Develop and review SOPs, DQs, IQs, OQs, and PQs, as well as change controls for process equipment.
  • Execute equipment/systems qualifications and validation protocols.
  • Support vendors' qualification functions and coordinate equipment/facility-related change control, deviations, CAPAs, and Capital Projects.
  • Communicate cross-functionally with customers, vendors, suppliers, contractors, and management on project-related activities.
  • Collaborate with manufacturing, formulation development, packaging, and Quality assurance personnel.
  • Analyze existing equipment and recommend modifications for process optimization.
  • Supervise 2 Mechanical Technicians.
Requirements
  • Bachelor's degree in Mechanical Engineering or Industrial Engineering, or Associates degree plus 2 years of experience.
  • 3 years of experience in the job offered or as a Sr. Technical Service Engineer.
  • Skills and working knowledge of IQ/OQ/PQ, CAPA, API, PLC, FDA regulations, and cGMP/SOPs.

Please submit your resume referencing job code SAM014 to HR at Granules Pharmaceuticals, Inc.