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Sr. Mechanical Engineer
2 months ago
Job Type Full-timeDescriptionAs a Sr. Mechanical Engineer, you will oversee, evaluate, maintain and calibrate equipment, and procedures used in the development and production of pharmaceutical products, while ensuring safety, quality, and purity requirements are met.Responsibilities include but not limited to: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 including training, direct work responsibilities, etc. Other duties assigned by management, as needed. RequirementsMinimum Education & Experience:Must have a Bachelor degree in Mechanical Engineering or Industrial Engineering with at least 3 years experience as a Sr. Technical Service Engineer highly preferred OR Associate's Degree with at least 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.
