To share my 30+ years of instrumentation and supervisor experience with a company that shares my dedication to excellence. To help pharmaceutical companies develop and maintain a calibration program that exceeds cGMP expectations.

Central Net Enterprises, LLC | Monroe, NY
Pharmaceuticals

Central Net Enterprises is a consulting/contracting service company specializing in pharmaceutical manufacturing equipment controls, instrumentation calibration and installation services.

Responsibilities include:

• Provide calibration services and consulting to the pharmaceutical industry.
• Calibration of various instruments and control systems.
• Troubleshooting and repair of equipment and instruments.
• Review and write SOP’s and Calibration Procedures.
• Maintain calibration database (utilizing Blue Mountain Calibration Manager).
• Execute validation protocols on various manufacturing equipment and systems.
• Installation of fluid bed granulation equipment control systems.
• Qualification documentation development for many different pieces of equipment in the pharma industry.
• Qualification executions on various equipment in the pharma industry.
• Develop calibration and preventive maintenance program including setup and validation of CMMS/CCMS systems.
• Write and edit Standard Operating Procedures related to equipment calibration and maintenance.
• Software validation.

Over the years in this business, I have set up and maintained calibration programs for various companies, such as Bayer Consumer Care, Bristol Myers Squibb, Fuisz Technologies, Ohm Laboratories (Ranbaxy), Pfizer and a few smaller companies throughout the U.S.

Assisted in more than a dozen installation projects, mostly fluid beds and coating pans.

Instrumentation and controls technician, Supervisor of instrument shop, Able troubleshooter, Organizational Leadership, Customer Service, Strong computer skills in many applications, and a good multitasker.

Firm understanding of the importance of cGMP in the pharmaceutical environment.

MikeFilsaime.com, Inc. | Ronkonkoma, NY
Internet Services

Project Manager for new products and project updates.

MikeFilsaime.com, Inc. is a leading internet product development and quality training company focused on marketing. In business since 2004, it is one of the fastest growing companies of this type on the internet today.

Responsibilities include:

• Manage the development and progress of new and existing products and services.
• Work closely with programmers to keep projects on schedule.
• Suggest and implement features and improvements to products and services.
• Assist in the launch of all new products.
• Assist in high level customer support, focusing on technical issues and assistance.
• Assist in the planning of all new product ideas from start to launch.

Par Pharmaceutical, Inc. | Spring Valley, NY
Pharmaceuticals

Instrumentation Supervisor responsible for the overhaul and day to day operation of the Instrument Calibrations department.

Responsibilities include:

Planning and Calibration of all specified instruments throughout the pharmaceutical manufacturing and research and development departments. Equipment includes: Fluid Bed Dryers and Granulators, tablet coating pans, drying ovens, blenders, Fitzmills, Nanomill and associated equipment, HVAC systems for GMP areas.

• Troubleshoot any equipment and control system failures, repair and test
• Write and update calibration SOPs
• Write and execute qualification and validation documentation
• Update control systems as needed
• Train calibration personnel
• Coordinate outside vendors as needed, including securing competitive bids, selecting vendors and completing all scheduling
• Assist in department budget planning as required for calibration area
• Supervise calibration technicians
• Perform yearly reviews on calibration technicians

Upon assuming the position of instrumentation supervisor, I updated the department considerably. This includes, but not limited to:

• Complete overhaul of the SOPs
• Calibration Manager software upgrade and validation
• Phase out any outdated calibration equipment
• Purchase needed calibration equipment
• Overhaul the way all scales and balances were calibrated
• Plan and add an environmental monitoring system for all of manufacturing (RH, Temp and D/P monitoring)

Proficient in the use of:

• Blue Mountain Calibration Manager
• Microsoft Word
• Microsoft Excel
• Dreamweaver
• Adobe Acrobat
• Crystal Reports

Quality Service Innovations, Inc. | Chester, NY
Pharmaceuticals

Responsible for operation of Technical Service Department of Pharmaceutical Equipment Service Company.

Supervision and training of Field Service groups to complete all tasks involved in Installation, Validation (I.Q., O.Q. & P.Q.), Maintenance and Equipment Instrumentation Calibration of Customer Facilities and Processing Equipment.

Responsible for interfaces with Quality Control and Auditing Agencies for development of and conformance to Standard Operating Procedures for Calibration, Preventive Maintenance and Validation Programs.

Proficient knowledge of Word Perfect Office 2000, Windows 98, Paradox 9.0, Quatro Pro 9.0, various environmental control programs and PLC controls.

Merck and Company | Rahway, NJ
Pharmaceutical

Plan and schedule all work relating to instrument calibration and preventive maintenance. Responsible for four (4) factory areas. Ensure all work is assigned to Instrument Technicians and completed by the required completion date to ensure minimal down time.

Write and review IQ and OQ documents for all new instrument installations as well as retrospective validations and qualifications. Write and review instrument calibration SOP’s. Work extensively with Maximo.

Glatt Air Techniques, Inc. | Ramsey, NJ

Responsible for Field Services to troubleshoot, repair and calibration of customer equipment around the country.

Schedule and perform preventive maintenance tasks. Research and write standard operating procedures for the calibration of instruments.

Responsible for ensuring the S.O.P.’s are current.

Assist various Facilities groups to complete all tasks involved in Manufacturing and R&D Equipment, Calibration, Maintenance, Validation and Repairs.

Responsible for interface with Engineering Departments and Customers Returns for, repairs/rebuilds to Fluid Bed Dryers, Pan Coaters, High Shear Granulators and related Pharmaceutical Processing Equipment.

Perform calibrations, preventive maintenance and validation on OEM equipment.

Draft Standard Operating Procedures and maintenance tracking documents for Calibration, Maintenance and Validation Programs.

Maintain equipment upgrade files and database(s) pertaining to retrofits modifications and repairs.

Principle calibration and repair technician on pneumatic and electronic instrumentation and related components.

Technical writing of Standard Operating Procedures for the calibration of instruments

United Parcel Service | Paramus, NJ

Supervise day crew of 7 maintenance mechanics and helpers, and a night cleaning crew of 15. Responsible for general building maintenance and repairs. Installation of basic electrical and communication wiring. Coordinator of all service vendors for facilities maintenance.

United States Navy | Various Locations

Responsibilities include testing, troubleshooting and repair of aircraft electrical and electronic systems. Quality Assurance inspector. Technical Publications Library specialist.