Instrumentation, Validation & Quality Assurance Engineer
Summary of qualifications Over 30 years experience, this includes the following:
- Instrumentation control system development and implementation. These include Process Control, Water System, HVAC, Clean Room, Analytical instrumentation, Packaging Equipments, Waste treatment, Sterilizer and Steam Turbine Combined/Cogeration.
- Validation of process/packaging equipment, HVAC/clean rooms, aseptic filling and sterilization (Steam/Ethylene Oxide/Gamma).
- Provide leadership and training in process validation, software validation, test method validation and data analysis.
- Quality Assurance overseeing all FDA and ISO 13485 (Medical Device) compliance.
- Perform instrument calibration per ISO/ANSI/NIST or any government regulation requirements.
- Support all quality system activities leading to improve compliance with corporate policies, 21CFR820, ISO 9001, ISO 13485, ISO 14971, the Medical Device Directive, the Canadian Medical Regulation (CMDR) and other applicable regulatory agencies.
- Insure that all projects are in compliance with GLP, QSR (including Design Controls), ISO or other applicable requirements.
- Bachelor Degree in Electrical & Chemical Technology
- Associates Degree in Electronic Technology
- Manager for all capital projects.
- Responsible for all the validation of the equipment used for production and packaging.
- Responsible for FDA compliance.
- Responsible for ISO 13485 (Medical Device) compliance.
- Prepares and manages regulatory submission (US/EU).Submissions include 510k.
- Responsible for the maintenance and calibration of the equipment used for production, packaging and research.
- Responsible for monitoring of clean room activity.
- Responsible for all production activity.
- Manager of Quality Assurance.
- Responsible for all Standard Operation Procedure (SOP) used for production, packaging, research, FDA and ISO 13485 (Medical Device) compliance.
- Managed capital project at the New York City Transit Metropolitan Transportation Authority (MTA). Supervise Installation of HVAC equipment and instrumentation; perform field service start-up, instrument installation and calibration for the all instrumentation. Write equipment start-up and instrument calibration procedure. Custom assembly of O & M Manuals.
- Managed capital project at the New York City Department of Environment Protection (DEP). Supervise installation of HVAC instrumentation; oversee the installation, engineering and start-up calibration of all instruments. Write equipment start-up and instrument calibration procedure. Custom assembly of O & M Manuals. Review shop tested instrument panels.
- Write Standard Operation Procedures (SOP).
- Review all cGMP, ISO and FDA compliance.
- Write Instrumentation and Mechanical preventive maintenance order.
- Perform Instrument calibration and Mechanical preventive maintenance.
- Supervise and perform field service and start-up for the equipment.
- Perform validation all on start-up and existing equipment.
- Managing 2 Instrument Supervisors and 3 Instrument Engineers.
- Perform administrative duties.
- Write standard operation procedures for all process and analytical Instruments.
- Review all cGMP and FDA compliance.
- Review all preventive maintenance order.
- Assist maintenance mechanics and supervisors in troubleshooting structural problems with shop personnel.
- Review all out-sources preventive maintenance order.
- Establishing instrumentation preventive maintenance order.
- Served as a lead engineer for start-up of new projects and upgrades.
- List of some of the projects work on: Water system, HVAC, Sterilizer, Batching tanks, Power distribution, Programmable controller and Environmental/Refrigerant Chamber.
- Perform administrative duties.
- Responsible for work assignments of 14 Instrument Technicians.
- Interface with vendors and sub-contractor for information in design efforts.
- Coordinate engineering, service contractors, and trade union groups for the fabrication, installation, and start-up of instrument/control systems for the purpose of minimizing project costs and over-run.
- Responsible for troubleshooting structural problems with shop personnel.
- Write standard operation procedures for all process and analytical instruments.
- Responsibilities include installation of new instrument system.
- Repair of all process and analytical instrumentation for medical research, quality control, biological, and production.
2006 - 2012 Confidential, Chatham, New Jersey
Validation Engineer/Project Engineer/Quality Assurance Manager
2005 - 2006 Confidential, Mount Vernon, New York
Project Manager (Temporary)
2003 - 2005 Confidential, Highland Mills, New York
Engineer, Consultant (Self Employed)
1980 - 2003 Confidential, Pearl River, New York
1993 - 2003
1987 - 1993
1980 - 1987
Computer Skills Operating Systems: All Microsoft Windows. Software: All Microsoft office (Word, Excel, Access Outlook, PowerPoint), Lotus Suit, Auto-Cad Solid Work and other programs similar to those. Able to utilize Internet resources to the fullest potential.
Reference: Available upon request.