Maintenance Equipment Engineer Manufacturing Manager
|FEREYDOUN (FRED) NAGHAVI
** ****** ******, ******** ****, ON L4E 4Z2 ~ (905) ***-**** ~ firstname.lastname@example.org
“Certified Engineer Technologist” in a highly regulated industries with experience in Calibration, Maintenance, Equipment Commissioning and Qualification (IQ, OQ, and PQ).
Overall responsibility for administration of Calibration Database Manager, for Calibration and Maintenance activities and Schedules.
Extensive knowledge of Temperature Mapping of Environmental Chambers and Warehouse.
Solid Understanding of Boiler, HVAC and Building Automation Systems. Pneumatics and Electronic Control Systems.
Solid knowledge of facility maintenance; available technologies to support facility and security systems.
Working knowledge of AutoCAD and MS Office applications.
Working knowledge of cGMPs, and regulatory requirements (TPP/FDA).
Familiar with WHMIS, Building Codes and the Occupational Health and Safety Act.
Well interaction with various departments in audits, safety, SOPs, and continuous improvement projects.
Excellent interpersonal skills, organizational and the ability to work well within a team.
Alphora Research Inc.
R & D Technician June, 2011- Present
Working knowledge of Reactor, Dryers, Filtrations Equipment, Glass Receivers, Blenders, Process Pumps, Column, and Rotary Evaporator.
Performed the preparation of process engineering and unit operations aspects of batch processing.
Executed of operations to cGMP standards for unit operations, Equipment Status, Log and Batch/Operations records.
Carried out chemical processing operations using state of the art reactors and supporting process equipment.
Performed preventive maintenance and calibration activities.
Performed cleaning of chemical processing equipment and facilities.
Received, sampled, labelled and ship chemicals and products.
Worked in accordance with Environmental, Health and Safety Procedures, Standard Operating Procedure, Production Batch Records and Good Manufacturing Practices.
Working knowledge of Draining and Sampling Procedures for Sanitary and storm Sewer spill containment tanks.
Responsible for complying with scheduled operations activities.
Interact with all personnel throughout the company to ensure the timely and safe execution of processes.
Work harmoniously with all fellow employees.
Interact with cGMP auditors as required.
FEREYDOUN (FRED) NAGHAVI 2
Performed other related duties as required.
Mylan Canada ULC (formerly Genpharm ULC) 1997 - 2011
Instrumentation/Facility and Project Specialist
Supervised and assisted with the installation and commissioning of new equipment, new chambers and interact well with others for the exchange of ideas and knowledge.
Wrote, reviewed and executed Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualifications (PQ) and SOPs.
Developed URS and PSR.
Strong ability to manage multiple projects simultaneously utilizing sound knowledge of Project Planning and Execution.
Knowledge of Piping and Instrumentation Diagram (P&ID), HMI (Human Machine Interfaces), PID temperature controllers, chart recorders, PLC’s.
Temperature Mapping of Incubator, Freezers, Chambers and Warehouse to insure that it provides optimal environment for development of microorganisms.
Responsible for the troubleshooting and maintenance of Stability Chambers.
Implemented and modified Qualification of a Building Automation system.
Responsible for the troubleshooting and management of Temperature / Humidity and Differential Pressure Monitoring Systems.
Analyzed and provided suggestions to improve process efficiency.
Taking swabs for cleaning validation of equipment and rooms for microbiology testing. Performed air monitoring using MAS 100 Air Sampler.
Taking water samples for Microbiology testing, and using applied aseptic techniques when sampling.
Calibrated and maintained specifications for new equipment and assuring that all calibration activities are completed in a timely manner.
Calibrated Anatel of Total Organic Carbon Analyzers (TOC) for purified water system and familiar to lab equipments: HPLC, GC, Dissolution and PH meters.
Served as primary and responsible contact for outside calibration services.
Performed calibration for various equipment and instruments: Transmitters, Flow Meters, RTD, Hardness and Thickness Tester, Disintegration and Balances.
Reviewed and approved the calibration documentation and coordinated implementation of calibration procedures according to NIST.
Troubleshoot controls and computer problems and if necessary, co-ordinate methods to resolve them with contractors and/ or colleagues.
Performed daily testing of Boilers, Cooling Systems and Maintained daily logs for system checks. Performed emergency calibration and maintenance on facility equipment and building systems.
Performed Machine Set-up for Operation, Trouble-shooting and any other services in Manufacturing, Packaging and QC areas.
Wrote several Standard Operating Procedures and trained the operators and mechanics on the operation, cleaning and preventive maintenance of new and refurbished pharmaceutical equipment.
Performed PM work order and equipment/component improvement or replacement.
Strive to reduce cost of unnecessary equipment/component replacement while improving overall equipment operation.
FEREYDOUN (FRED) NAGHAVI 3
Assisted in developing annual facility maintenance budgets; track spending according to budget targets; assisted in developing cost reduction strategies.
Supervised and Coordinated Contractors and trained team members.
Ability to analyze equipment malfunctions and selects an appropriate course of action and maintained manufacturing mechanical & electrical parts inventory.
Maintains accurate records of equipment including history, costs, and duration of work.
EDUCATION AND PROFESSIONAL DEVELOPMENT
Master of Engineering, Power and Machinery
Bachelor of Technology in Agricultural Engineering
Industrial Electronics, D.C.Circuits, Process Instruments and Automation Control, Humber College, 2011
Good Manufacturing Practice (GMP) courses, Mylan, 2009
Certificate of Code of Conduct, Genpharm, 2005
Commissioning and Validation of Pharmaceutical and Biotechnology Facilities Course, University of Toronto, 2003
Fire Extinguisher Operator Training Certificate, Mylan, 2003
AutoCAD, Seneca College, 1998
Geographical Information System Application Specialist Course, Sir Sanford Fleming College, 1996
Certified Engineering Technologist (CET) in Ontario
Member: Instrumentation, System and Automation society of America (ISA)-USA.
Member: Pharmaceutical Science Group (PSG) Canada.
Professional Engineers of Ontario (PEO) - under process
York Region District School Board 2010-2011
Certificate of Appreciation for significant contributions
and volunteer efforts.
Mylan Canada Inc., Toronto 1998-2010
Organized and member of Mylan’s Marathon Relay Team.
Dovercourt Boys and Girls Club, Toronto 2009
Organized extra-curricular activities, played games, taught computer usage.
Promoted self-confidence in youth.
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