Granules Pharmaceuticals Inc., (GPI) is a subsidiary of Granules India LTD.  Over the past 34 years, we have worked towards strengthening our core and we are the 10th fastest growing generic pharma company in the US! With our sites in Chantilly and Manassas, Virginia, we have R&D through manufacturing and packaging of our medicines including pulsatile drug release in tablet and capsule dosage form, orally disintegrating modified release tablets (XR, MR, ER), modified release suspension and controlled substances capabilities in an abuse deterrent technology platform.

We are dedicated to excellence in manufacturing, quality, and commercialization of generic drugs to give customers reliable and affordable options. 

As a Mechanical Engineer (Chantilly, VA) for Granules Pharmaceuticals Inc, the job duties include but not limited to:

• Oversee, evaluate, maintain and calibrate equipment, and procedures used in the development and production of pharmaceutical products; 
• Ensure safety, quality, and purity requirements are met; 
• Ensure equipment is suitable for its intended use through the development and execution of qualification documentation to support the System Life Cycle, including facilities, utilities, equipment, and automation; 
• Ensure compliance by following government regulations including but not limited to, FDA (21 CFR 210/211 and Part 11), EMA and company policies; 
• Develop and review SOP, DQ, IQ, OQ and PQs, and Change controls for all process equipment; 
• Execute equipment/systems qualifications and validation protocols; 
• 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; 
• Co-ordinates with manufacturing, formulation development, packaging, and Quality assurance personnel on an everyday basis; 
• Perform evaluation studies and validation of manufacturing equipment, utilities, and systems;
• Analyze existing equipment and recommends modifications for process optimization; 

Minimum Education & Experience:

•  Must have a Bachelor degree in Mechanical Engineering or Industrial Engineering plus 3 years experience, Master's Degree preferred. 
• Require skills and working knowledge of IQ/OQ/PQ, CAPA, API, PLC, FDA regulations, cGMP/ SOPs.  
• Experience working in a pharmaceutical manufacturing environment is highly preferred.