Montgomery Street, San Francisco, CA94105(555) 432-1000, resumesample@example.com
Objective
Enthusiastic systems and validation engineer, eager to contribute to team success through hard work, attention to detail and excellent organizational skills. Clear understanding of system modeling, verification and validation. Motivated to learn, grow and excel in profound field of Pharmaceutical Industry.
Work History
07/2019 to CurrentEngineering and Safety ManagerFreeport-Mcmoran Copper & Gold Inc. | Safford, AZ,
Prepare URS (User Requirement Specifications) and design the system structure in accordance with the need of production flow and management requirements
Perform design, verification and validation studies on the systems required in manufacturing or packaging to ensure system compatibility against the defined URS
Perform risk assessment using appropriate risk management tools to estimate and evaluate high risk parameters in terms of integration of different equipment at design stage and apply appropriate risk mitigation techniques in terms of project management for any particular system
Conduct FAT [Factory acceptance testing] to verity the parameter functioning as defined in URS and release the equipment to be delivered at production facility.
Upon receiving the equipment at respective unit, perform the site acceptance testing [SAT] using design qualification protocol to cross verify the equipment parameter is functioning as intended.
Write / Review IQ/OQ/PQ protocols and execute to validate the critical equipment parameters related to installation, operation, and performance of the relevant equipment [manufacturing filling/ packaging] for multiple dosage form including Solid and Liquid.
Design and execute facility qualification protocols [IQ, OQ, and PQ] with execution summary reports.
Develop and review new SOPs, forms, logs and records for facilities/maintenance, safety procedures and equipment [manufacturing and packaging].
Design of cleaning procedures and cleaning validation studies with coordination of quality systems to achieve maximum cleaning efficiency of facility / equipment and determine cleaning criteria for cleaning agent residue along with sampling locations.
Coordinate with vendors and execute the projects for facility construction / modification, equipment purchase, calibration schedule and/or Preventive Maintenance schedule including air handling systems and steam boilers.
Design facility for production follow, personnel and material flow in AutoCAD in accordance with FDA guidelines.
Training of employees on work related hazards, safety measures and encouraging them to develop a safe working culture in the facility to avoid any accidents or injuries
Perform Troubleshooting on PLC, AC Drives, electric motors in case of any mechanical or electrical breakdown on equipment.
Testing of Fire sprinklers and schedule planned maintenance.
Experience of handling computerized maintenance management system [CMMS system]
Promoted worksite safety by implementing enhanced lockout and tagout maintenance processes.
Reduced injuries among personnel with development and implementation of robust safety programs and policies.
Reduced worker's compensation premiums through monthly near miss reporting meetings.
Inspected job sites and facilities to detect potential health hazards and put corrective measures immediately into effect.
02/2019 to 07/2019Facility Validation EngineerLeading Pharma LLC | City, STATE,
Design and execute facility qualification protocols [IQ, OQ, and PQ] with execution summary reports.
Managing facility construction and modification projects ensuring that the designs meet FDA regulations and air flow as well as production flow are in compliance with FDA guidelines.
Review and revise SOPs, forms, logs and records for facilities/maintenance.
Write and execute IQ and OQ protocols for new equipment in manufacturing filling, and packaging for solid, liquid and topical dosages.
Schedule, perform and maintain preventive maintenance of facility systems, manufacturing equipment and packaging equipment.
Troubleshoot and identify the cause of the problem when any deviation is noted.
Record keeping of repair work orders and change controls for facility repairs and modifications
Documented entire validation process, noting changes or alterations completed.
Identified causes of equipment failures and made suggestions for issue resolution.
01/2017 to 02/2019Chief Electrical EngineerAnglo Eastern Ship Management | City, STATE,
Created, aligned and optimized electrical instrumentation and testing equipment.
Created electrical schematics using AutoCAD Electrical Toolset.
In charge and responsible for operation, maintenance and troubleshooting of ship’s electrical systems and equipment such as Diesel Generators (1600 kW – 2800 kW), Switchboards, Distribution and Group Starter Panels (6.6 kV, 440 V, 220 V, 24 VDC), Navigation System, Radars, Fire Detection and protection System, Auxiliary Machineries, Motors, Compressors, LPG Re-Liquification Plat .
Testing / Calibration of onboard Temperature, Pressure and Vacuum sensors/switches, calibration of PID controllers for high pressure steam boilers and fresh water generators
Hands on experience in operation, maintenance and troubleshooting of PLC and SCADA system.
Prepare performance reports of all running and stand-by machinery including motors, generators, engines, boiler, chiller plants, refrigeration plants, compressors and radars every month, quarter and year.
Performing maintenance routines as per Planned Maintenance Schedule (PMS) for each machinery onboard ship
Maintaining all generators and power system of ship’s main switchboard including AVR in stand-by and ready to run condition for any emergency.
Education
Expected in 04/2021Masters of Engineering | Engineering Management And Systems EngineeringStevens Institute of Technology, Hoboken, NJGPA:
Concentration in System Design, Verification and Validation
Expected in 07/2016Bachelor of Engineering | Electrical EngineeringGujarat Technological University, Gujarat, India, GPA:
Skills
Safety audits
Safety Program Development
Keen Learner and result oriented approach
Excelled planning and capabilities
Effective communication and decision making power
Lock out tag out programs
Risk Identification
Confident and Skilled applicator
Organized and transparent attitude
Diversified academic background in System Design and Validation
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