Sr. Mechanical Engineer; Chantilly, VA

Description

Sr. Mechanical Engineer (Chantilly, VA) for Granules Pharmaceuticals Inc. The job duties include but are not limited to the following responsibilities and requirements.

• 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 SOPs, DQ, IQ, OQ and PQs, and Change controls for all process equipment
• Execute equipment/systems qualifications and validation protocols
• 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
• Coordinate with manufacturing, formulation development, packaging, and Quality Assurance personnel on a day-to-day 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 recommend 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 a related role. As an alternative, an Associate’s Degree plus 2 years experience is acceptable.
• Required skills:
  
  IQ/OQ/PQ, CAPA, API, PLC, FDA regulations, cGMP/SOPs

Chantilly, VA

• Submit résumé referencing job code SAM
  014 to HR, Granules Pharmaceuticals, Inc., 3701 Concorde Parkway, Chantilly, VA 20151
• Seniority level:
  Mid-Senior level
• Employment type:
  
  Full-time
• Job function:
  Engineering and Information Technology
• Industries:
  Pharmaceutical Manufacturing