Calibration/Project Specialist

FEREYDOUN (FRED) NAGHAVI

** ****** ******, ******** ****, ON L4E 4Z2 ~ 905-***-**** ~ ***********@*****.***

INSTRUMENTATION ENGINEER

A Certified Engineer Technologist with over ten years experience in a pharmaceutical and biotech industries. Strong working knowledge of pharmaceutical manufacturing and packaging equipment. Thrives on the challenge of meeting production and operational requirements through engineering methodology. A diligent and high productive engineer, often completing projects ahead of schedule. Good time management, decision- making, presentation, and organization skills. Ability to manage multiple projects and interact well with others for the exchange of ideas and knowledge. Excellent teamwork, communication and problem-solving skills with substantial technical and mechanical aptitude. Thorough knowledge of GMP standards and FDA regulations.

EXPERIENCE

Mylan Canada ULC (formerly Genpharm ULC) 2000 - Present

Instrumentation and Project Specialist

 Managed installation and commissioning of new equipment, new chambers and software for engineering and manufacturing departments.

 Wrote, reviewed and executed Installation Qualification, Operational Qualification, Performance Qualifications and SOPs.

 Validated HMI (Human Machine Interfaces), source codes, drawings, PID temperature controllers, chart recorders and PLC’s.

 Supported and administered calibration database manager and software, for calibration and maintenance activities and schedules

 Completed all calibration activities on equipment and instruments in a timely manner by setting calibration and maintenance specifications for new equipment

 Performed calibration for various equipment and instruments: granulation, coating, drying, disintegration, hardness and thickness tester, balances, transmitters, flow meters, and RTD.

 Calibrated Anatel of Total Organic Carbon Analyzers (TOC) for purified water system.

 Reviewed and approved the calibration documentation and coordinated implementation of calibration procedures according to NIST.

 Served as primary and responsible contact for external vendors and contractors

 Performed machine set-up for operation, trouble-shooting and any other services in Manufacturing and Packaging 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.

 Troubleshoot controls and computer problems and if necessary, co-ordinate methods to resolve them with contractors and/ or colleagues.

 Designed new jaw plates to accommodate different shapes of tablets for Hardness Tester.

 Designed changes to calibration weights and the platform to improve the calibration of hardness tester.

 Modified temperature control system of Disintegration tester by adding chiller coils to accommodate temperatures ranging from 37c to 20c. for the protocols.

 Purchase equipment & spare parts.

 Involved in process and cleaning validation.

 Wrote specification for Mapping, procured, commissioned and used data logger and sensors for mapping of incubator, freezers, stability chambers and warehouse.

 Troubleshoot and maintained Stability Chambers, Temperature, Humidity and Differential Pressure Monitoring Systems.

 Validated the autoclaves using biological indicators.

 Implemented and modified Qualification of a Building Automation system.

 Working knowledge of AutoCAD and MS Office, HVAC, Pneumatics and Electronic Controls.

 Performed other duties as required.

Enghouse Systems Limited 1996-1997

Quality Assurance Engineer

Glaxo Wellcome Inc 1992-1995

Maintenance Technician

EDUCATION AND PROFESSIONAL DEVELOPMENT

Master of Engineering, Power and Machinery

Bachelor of Technology in Agricultural Engineering

D.C.Circuits, Process Instruments and Automation Control, Humber College, 2009

Good Manufacturing Practice (GMP) courses, Mylan, 2009

Certificate of Code of Conduct, Genpharm, 2005

Commissioning and Validation of Pharmaceutical and Biotechnology Facilities Certificate, University of Toronto, 2003

Programmable Logic Controller, Allen Bradley, Centennial College, 2003

Fire Extinguisher Operator Training Certificate, Mylan, 2003

Certificate of AutoCAD, Seneca College, 1998

Geographical Information System Application Specialist, Sir Sanford Fleming College, 1996

PROFESSIONAL MEMBERSHIPS

Certified Engineering Technologist (CET) in Ontario

Member: Instrumentation, System and Automation society of America (ISA)-USA.

Member: Pharmaceutical Science Group (PSG) Canada.

VOLUNTEER WORK

Dovercourt Boys and Girls Club, Toronto 2009

 Organized extra-curricular activities, played games, taught computer usage.

 Promoted self-confidence in youth.

Mylan Canada Inc., Toronto 1998-2010

 Organized and member of Mylan’s Marathon Relay Team.

Contact this candidate