Mechanical Engineer

Granules Pharmaceuticals
Chantilly, VA
Mar 15, 2019
Mar 18, 2019
Full Time
Maintain the facility and equipment in a good operating condition as per Production and FDA requirements. Manage the design, planning, construction, and maintenance of building, utilities, equipment and other facilities system. Thorough knowledge of Good Manufacturing Practices (GMP), Good Engineering Practices (GEP) and some knowledge of Good Lab Practices (GLP) Implement and manage all security system pertaining to the building to secure the site and to adhere DEA compliance standards. Coordinate and maintain all personel in the production, warehouse and maintenance records on safety gear and safety equipment usage. Perform all EHS related activiites including personnel training on safety procedures in the production floor and overall site solvent handling at warehouse, production and laboratory. Knowledge of handling hazardous chemicals, Virginia DEQ environment air permitting regulations waste water treatment system, Environmental Protection Agency (EPA) regulations, fire codes, building codes, fire wet sprinkler system, building alarm system, local and state government regulations relating to the facility systems. Maintain all necessary documents as per Food and Drug Administration (FDA) standards. Write, execute and review installation qualifiaciton (IQ) , operational qualfication (OQ) and performance qualification(PQ) protocol of equipment, facility and utilities. Write, execute and review standard operation procedures (SOP), perform investigation into quality incidents, initiate corrective and preventative actions (CAPA) and check for CAPA effectiveness. Analyze trends in data in order to provide accurate descriptions, identify root causes, and/or indenity solutions or improvements. Initiate, maintain and review work order procedure system related to manufactuirng equipment and utilities. Comprehensive hands on knowledge of pharmaceutical manufacturing processes and ability to troubleshoot equipment and utilities related to facility operation. Managing budget on facility expanision and maintenance perferred Troubleshoot large scale integrated circuit motors, variable frequency drives, programming login, controllers, relays starters, contractors, etc., used in pharmaceutical manufacturing equipment. Assisting, coordinating and supervise equipment commissioning, qualification and validation activities. Coordinate HEPA filter certification, particle count testing, microbial testing, air flow testing, room pressurization techniques and other related tests to comply with Class 100,000/ISO 8 GMP requipments. Perform engineering managment of any electrical facility updgrades and or expansion Manage and coordinate the facility and equipment work either through internal resources or with outside contractors Enforce strict safety procedures on process, laboratory and engineering activities. Analyzing and reacting to project estimates and faciliting capacity and process constraints. Managing costs to justify various tools, equipment, processes or method improvements for cost reduction, qulaity improvements, innovaiton, safety and improved process efficiency. Cooridnate and support warehouse production and laboratory team on facility related issues. Periodically train facility mechanics Maintain and execute the scheduled preventative maintenance and calibration program activities Execute and maintian PM and Calibration Prgoram using computerized maintenance management system Maintain inventory of equipment spart parts used in the production equipment and utilities. Knowledge & Skills: Qualifying experience must include working and troubleshoot larde scale inegrated circuits, motors Experience & Education: Position requires a minimun of a Bachelor/Master's degree or foreign equivalent in Electrical or Mechanical Engineering. Scient or realted field plus, 3-7 years of experience in the position offered or in any position/title providing experience with working on large scale integrated circuits and performing installations, qualificaitons and upgrades of machines. In leiu of Master's degree and 2 years of expereince, employer will accept Bachelor's degree or foreign equivalent in Elctrical or Mechanical Engineering, Science or related field plus 5 years of progressive work experience with working on large scale intergated circuits and performing installations, qualification and upgrades of machines. PM18 PI108468685

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