As a Sr. 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; 
• Lead team members while promoting a positive team environment; 
• Analyze existing equipment and recommends modifications for process optimization; 
• Supervise 2 Mechanical Technicians. 

Minimum Education & Experience:

•  Must have a Bachelor degree in Mechanical Engineering or Industrial Engineering plus 3 years experience in job offered or as Sr. Technical Service Engineer. As an alternative to Bachelor’s degree, Associate’s Degree plus 2 years experience is acceptable. 
• Require skills and working knowledge of IQ/OQ/PQ, CAPA, API, PLC, FDA regulations, cGMP/ SOPs.  

Job Location: Chantilly, VA. Submit résumé referencing job code SAM014 to HR, Granules Pharmaceuticals, Inc., 3701 Concorde Parkway, Chantilly, VA 20151.