Medical Device Project

RICHARD KISER / Independent Validation Engineer Page 1 of 5

ELIZABETH CITY, North Carolina 27909 Phone: 252-***-**** Email: ****@*******.***

SUMMARY

Independent Contractor, with over 18 years of engineering experience in Biotech and Medical Device Industries. My successes include authoring IQ, OQ and PQ Protocols for Facilities, Utilities, Equipment, Processes, Commissioning and CIP/SIP Cleaning Validation. Writing Validation Master Plans, User Requirements SOPs and Final Reports. My experience includes Aseptic and Medical Device Environments, familiar with ISO 9001 and 13485 regulations. Very knowledgeable of 21-CFR Parts 210-211, Gamp 4, HVAC Control Systems, (HMI) Human Machine Interface and Allen Bradley PLCs. I have always worked very well with company management and other company departments such as, Quality Assurance and Engineering.

PROFESSIONAL EXPERIENCE

SCIENTIFIC PROTEIN LABORATORIES Waunakee, WI 1/2011 to 6/3011

• This company was under several mandated warning letters, for various violations. They manufactured Heparin a human product that was an anti-coagulant for stopping blood clots. They were also a contract manufacturer in making Biological products for other companies. They had a major re-validation program for equipment, cleaning and an HVAC system.

• My responsibilities were to re-write an IOQ and a PQ for a warehouse HVAC system the held pre product chemicals and other substances in the making of Heparin. The HVAC system was a constant air volume, conditioning system that delivered approximately 4,5000 cfm of supply air that served the warehouse area. The HVAC system provided a minimum outside air requirement of 1,000 cfm, and exhausts approximately 600 cfm. The system operated continuously, except during shut down for maintenance. Some of the attachments listed in the protocol consisted of, Training Verification, a list of current calibration reports for each instrument, Verify that the utilities and environment requirements for the system met the specifications listed on Attachment and record all as built drawings associated with system. There was much more to these protocols, to much to list on this resume.

• I also wrote an IOQ and PQ for Getinge Castle Autoclave. The steam sterilizer was used for the sterilization of media, equipment, and supplies used in aseptic processing in the Quality Control Microbiology Laboratory as well as decontamination of biohazardous materials prior to cleaning and/or disposal. In this protocol I listed, all major components and associated equipment numbers of the sterilizer, Validation test equipment and materials Major components and equipment numbers, Equipment List; and Environmental Requirements and supporting Utilities. The sterilizer had the capabilities of being programmed for up to six (6) cycles. SPL had pre-programmed two (2) cycles, one 15 minute cycle, and one 30 minute cycle. Temperature Mapping was performed; Not less than (NLT) 12 thermocouples were utilized in the mapping studies. The thermocouples were placed throughout the sterilizers chamber, and as near as possible to the controlling temperature probe located in the exhaust drain of the unit. A one (1) inch port located on the side of the sterilizer chamber allowed thermocouple access to the chamber. A Honeywell DPR-3000 chart recorder monitored and record the temperatures.

RICHARD KISER Page 2 of 5

BIOVAIL PHARMACEUTICALS Virginia 2/2010 to 12/2010

• This is a pharmaceutical company engaged in the development and manufacturing of products for the treatment of respiratory infections, allergy conditions, and skin and soft tissue infections. My responsibilities were to review and update (OQ) Operational Protocols and (PQ) Performance Protocols for Biovails re-validation program and to meet all cGMP requirements. The (OQ and (PQ) protocols were for process equipment such as; Autoclaves, Parts Washer, Tunnel Sterilizer Dehydrogenation Oven and CIP cleaning.

• Some of the testing I listed in the PQ Protocols were; overall average of (RTD) temperature during exposure period, Temperature Probes upstream and downstream of filters. There was more testing performed too numerous to list on my resume. Also wrote several Final Reports.

• Verified that all test were addressed and listed, and that all Thermocouples and Biological Indicators had Diagrams for proper placement.

• I described testing for the Autoclaves that addressed any cold spots during full load cycle time. I also listed in the protocol testing for TOCs and Conductivity for CIP Cleaning.

MEDRAD MEDICAL Pennsylvania 6/2009 to 12/2009 Division of Bayer

• My responsibilities were to write IOPQ Protocols and Final Reports for validating 8 new Incubators, 4 new Refrigerators and 3 new Depyrogenation Ovens. All mentioned equipment was monitored by Dickson Chart Recorders. Performed temperature studies and thermo mapping.

• In the OQ section of the protocol I addressed testing of Control Alarm Indicators. The objective of this test was to verify the function of system controls and alarm indicators, which included the units display and settings. All calibrated instruments that were used during execution phase were verified as to their present calibration status.

• In the PQ section of the protocol I described how thermo mapping would be used for placement of various Thermo Couples when using the Kaye Validator 2000. I also included the Kaye Validator Calibration test. This test was to verify that the Kaye Validator was calibrated correctly prior to temperature distribution and recovery testing. This was all part of Medrads Process Validation for new equipment and the manufacturing of various types’ medical syringes.

SANDVIK MEDICAL SOLUTIONS Tennessee 2008 - 2009

• I was the Validation Lead Person for a new Contract Medical Device start up company that manufactures Class l, ll and class lll medical device instruments, the class lll instrument was a surgical implanted spinal device.

• My duties were to write a Facility Validation Master Plan to qualify Sandvik’s new facility and to provide the overall validation strategy on what would be required for Commissioning, Validating and new facility start up developing IQ, OQ and PQ Protocols for their new facility and process manufacturing equipment. I also gave directions to management on Process Validation requirements under 21 CFR: Parts 210/211.

• Authored IQ & OQ. Protocols for qualification requirements for new facility, utilities and all construction activities to assure all GMP requirements were met prior to FDA inspection.

• The IQ and OQ protocols consisted of, facility description, type and size of the building, supporting utilities such as rooftop HVAC units, Electrical system and all components, Compressed air system, As Built Drawings, P&ID diagrams, Facility Lighting, etc. I also instructed several training sessions for in-house employees on proper execution of these protocols.

RICHARD KISER Page 3 of 5

• Instructed Management on how to set up a new document control department for tracking documents so they could assure and maintain Good Document Practices.

• Outlined in the Master Plan what is required in an Engineering Design History File for any future new devices or to any changes made to their existing devices.

FORT DODGE ANIMAL HEALTH / Fort Dodge, Iowa (2005-2007), a division of Wyeth Pharmaceuticals Inc. Project Lead Person

• I was the Project Lead for a new Automation Building Management System (BMS) for HVAC controls. This involved changing over 23 HVAC units from an existing 20 year old Staefa system to a new Johnson Controls system. This was a major C A P A project at a cost of One-Point-Two Million Dollars ($1.200,000.00). This was mandated by the FDA for process validation for the company’s manufacturing areas and aseptic filling suites.

• My responsibilities for this project were to oversee all changeover activities from an existing Staefa Control system to a new Johnson Controls, Inc. Control system. I was responsible for over seeing all installation and Validation activities on a daily basis with Johnson Controls, Inc., Electrical Contractors and In-House personnel. This involved installing new Control Panels, new Control Cards, Re-Heat Coils, Freeze Stats, Bubble type Dampers, Zone Temperature Controllers, Humidifier controllers for controlled areas, new Setras, Allen Bradley Process Logic Controllers (PLSs), Critical and Non Critical alarms. There were 9 new Computers installed consisting of Engineering Workstations that were password protected, Monitoring Workstations and (OITs) Operator Interface Terminals.

• I Authored a User Requirements Specification Document (URS), for the BMS to include the functionality of the system for controls and monitoring activities. The URS document also defined the system requirements necessary for network communications, human-machine interface (HMI), printing, archiving, and hardware/software platforms. The scope of the URS is limited to defining the requirements for the network, servers, workstations, and controllers. Microsoft Windows 2000 operating system was utilized for all computer systems. The servers were loaded with the applicable vendor application software, 21 CFR Part 11/Annex11 OPC compliant. I also wrote IQ,OQ and PQ protocols for this new system.

• Attended weekly project status meetings to keep management informed of the progress and activities during the course of this project and other projects I was involved in.

JOHNSON & JOHNSON / Puerto Rico 2004 - 2005

• I was a Project Lead Person performing FAT testing on four large 30 shelves Lyophilizes. My responsibilities were to verify that all As-Built drawings for mechanical, electrical and control wiring drawings were certified.

• Validated the environmental chamber, including the verification of utility flow, pressure checks, and temperature monitoring using a Kaye Validator 2000. Verified all critical controlling instrumentation such as Allen Bradley Process Logic Controllers (PLCs) had been calibrated prior to execution of the FAT and were supported with a calibration certificate. Performed a complete check of the electrical systems and all wiring schematics.

• Verified and obtained the appropriate weld maps, certifications, and videotapes and preformed a 10% check of the welding log.

RICHARD KISER Page 4 of 5

SANOFI PHARMACEUTICAL / Pennsylvania 2004

• I Developed Project Validation Plan for a new class 100,000 Aseptic Suite that was being constructed with equipment and supporting utilities.

• In the validation plan I defined validation requirements for supporting utilities such as, chilled water, purified water, clean steam, plant steam, medical grade nitrogen, and compressed air.

• Defined validation requirements for High Potency Suite Airlocks and Air Flow including HVAC, HEPA filters and hourly air changes. Also Environmental Monitoring, an Interim Project Commissioning Checklist, Material Flow, Cleaning Deviation review.

• I authored IQ, OQ and PQ protocols for an Isolation Barrier for a new Aseptic filling line and a Kuhlman Autoclave. I also participated in executing these protocols.

SCHERING PLOUGH / New Jersey 2002

• I Worked on Critical Utilities that were mandated by order of a FDA Consent Decree. Wrote new Operational Qualifications for Re-Validation on the following systems: CIP, Compressed Air, Nitrogen and HVAC.

• Wrote Maintenance SOP’s for the CIP Cleaning and HVAC Systems addressing pumps, heat exchanger gasket and seal replacement, Pre Filters, Final Filters, HEPA Filters Fans and Fan motors. Also wrote some Assessments on what would be required for compliance on some of the utilities.

PHARMACIA / Michigan 2001 - 2002

• My responsibilities were to write a validation plan, an IQ. And OQ. Protocols along with overseeing proper test procedures were implemented for the execution phase for a re-validation project on a Sterile Packaging Line and Despatch Oven. This was Class lll Medical Device product for surgical sponges used in human surgery to stop excessive bleeding.

• I worked with the Engineering department for the installation of a new Chilled Water system for the manufacturing area.

• Assisted the Controls Engineers for proper placement of PLC’s, and a new Control Panel to be installed for manufacturing processes...

• Reviewed all IQ and OQ Equipment protocols along with critical utilities protocols.

• Prepared Final Reports along with addressing any Deviations that occurred during the execution phase.

GENETICS INSTITUTE / WYETH / Massachusetts 2000 - 2001

• Project Lead Person for Clean-in-Place (CIP) replacement project. Worked with in-house Validation, Manufacturing, and Engineering departments addressing Conductivity, TOC and, Phosphate issues with their CIP system.

• Preformed engineering study on the complete CIP system and CIP Skid with Transfer Lines, Buffer Tanks, Media Tanks and Bio-Reactors. Defined validation tests to verify and document the ability of the cleaning programs to re-move test solutions from vessels and transfer lines. Also worked on protocol writing, review, and re-validation assessments for a CIP new system.

RICHARD KISER Page 5 of 5

BAXTER HEALTHCARE / Thousand Oaks Facility, California 1999 -2000

• Project Lead, of 5 contractors, my responsibilities was to author IQ, OQ, & PQ Protocols for process equipment and critical utilities for a new Cell Culture production area. I was also responsible for overseeing the execution phases of these protocols.

• Equipment included Autoclaves, Media Tanks, Bio-Safety Cabinets, Incubators, Buffer Tanks, Depyrogenation Oven, Parts Washer, Harvest Carts, Centrifuges and Systems-CIP, SIP, WFI, Glycol and Clean Steam. Oversaw the installation of new equipment along with supporting utilities.

• I was responsible for completed final technical review that all Protocols were properly and fully executed. Addressed deviations that occurred during the execution phase were true deviations and were properly written and justified.

EDUCATION:

BSME Engineering

RICHARD KISER / Independent Validation Engineer Page 1 of 5

ELIZABETH CITY, North Carolina 27909 Phone: 252-***-**** Email: ****@*******.***

SUMMARY

Independent Contractor, with over 18 years of engineering experience in Biotech and Medical Device Industries. My successes include authoring IQ, OQ and PQ Protocols for Facilities, Utilities, Equipment, Processes, Commissioning and CIP/SIP Cleaning Validation. Writing Validation Master Plans, User Requirements SOPs and Final Reports. My experience includes Aseptic and Medical Device Environments, familiar with ISO 9001 and 13485 regulations. Very knowledgeable of 21-CFR Parts 210-211, Gamp 4, HVAC Control Systems, (HMI) Human Machine Interface and Allen Bradley PLCs. I have always worked very well with company management and other company departments such as, Quality Assurance and Engineering.

PROFESSIONAL EXPERIENCE

SCIENTIFIC PROTEIN LABORATORIES Waunakee, WI 1/2011 to 6/3011

• This company was under several mandated warning letters, for various violations. They manufactured Heparin a human product that was an anti-coagulant for stopping blood clots. They were also a contract manufacturer in making Biological products for other companies. They had a major re-validation program for equipment, cleaning and an HVAC system.

• My responsibilities were to re-write an IOQ and a PQ for a warehouse HVAC system the held pre product chemicals and other substances in the making of Heparin. The HVAC system was a constant air volume, conditioning system that delivered approximately 4,5000 cfm of supply air that served the warehouse area. The HVAC system provided a minimum outside air requirement of 1,000 cfm, and exhausts approximately 600 cfm. The system operated continuously, except during shut down for maintenance. Some of the attachments listed in the protocol consisted of, Training Verification, a list of current calibration reports for each instrument, Verify that the utilities and environment requirements for the system met the specifications listed on Attachment and record all as built drawings associated with system. There was much more to these protocols, to much to list on this resume.

• I also wrote an IOQ and PQ for Getinge Castle Autoclave. The steam sterilizer was used for the sterilization of media, equipment, and supplies used in aseptic processing in the Quality Control Microbiology Laboratory as well as decontamination of biohazardous materials prior to cleaning and/or disposal. In this protocol I listed, all major components and associated equipment numbers of the sterilizer, Validation test equipment and materials Major components and equipment numbers, Equipment List; and Environmental Requirements and supporting Utilities. The sterilizer had the capabilities of being programmed for up to six (6) cycles. SPL had pre-programmed two (2) cycles, one 15 minute cycle, and one 30 minute cycle. Temperature Mapping was performed; Not less than (NLT) 12 thermocouples were utilized in the mapping studies. The thermocouples were placed throughout the sterilizers chamber, and as near as possible to the controlling temperature probe located in the exhaust drain of the unit. A one (1) inch port located on the side of the sterilizer chamber allowed thermocouple access to the chamber. A Honeywell DPR-3000 chart recorder monitored and record the temperatures.

RICHARD KISER Page 2 of 5

BIOVAIL PHARMACEUTICALS Virginia 2/2010 to 12/2010

• This is a pharmaceutical company engaged in the development and manufacturing of products for the treatment of respiratory infections, allergy conditions, and skin and soft tissue infections. My responsibilities were to review and update (OQ) Operational Protocols and (PQ) Performance Protocols for Biovails re-validation program and to meet all cGMP requirements. The (OQ and (PQ) protocols were for process equipment such as; Autoclaves, Parts Washer, Tunnel Sterilizer Dehydrogenation Oven and CIP cleaning.

• Some of the testing I listed in the PQ Protocols were; overall average of (RTD) temperature during exposure period, Temperature Probes upstream and downstream of filters. There was more testing performed too numerous to list on my resume. Also wrote several Final Reports.

• Verified that all test were addressed and listed, and that all Thermocouples and Biological Indicators had Diagrams for proper placement.

• I described testing for the Autoclaves that addressed any cold spots during full load cycle time. I also listed in the protocol testing for TOCs and Conductivity for CIP Cleaning.

MEDRAD MEDICAL Pennsylvania 6/2009 to 12/2009 Division of Bayer

• My responsibilities were to write IOPQ Protocols and Final Reports for validating 8 new Incubators, 4 new Refrigerators and 3 new Depyrogenation Ovens. All mentioned equipment was monitored by Dickson Chart Recorders. Performed temperature studies and thermo mapping.

• In the OQ section of the protocol I addressed testing of Control Alarm Indicators. The objective of this test was to verify the function of system controls and alarm indicators, which included the units display and settings. All calibrated instruments that were used during execution phase were verified as to their present calibration status.

• In the PQ section of the protocol I described how thermo mapping would be used for placement of various Thermo Couples when using the Kaye Validator 2000. I also included the Kaye Validator Calibration test. This test was to verify that the Kaye Validator was calibrated correctly prior to temperature distribution and recovery testing. This was all part of Medrads Process Validation for new equipment and the manufacturing of various types’ medical syringes.

SANDVIK MEDICAL SOLUTIONS Tennessee 2008 - 2009

• I was the Validation Lead Person for a new Contract Medical Device start up company that manufactures Class l, ll and class lll medical device instruments, the class lll instrument was a surgical implanted spinal device.

• My duties were to write a Facility Validation Master Plan to qualify Sandvik’s new facility and to provide the overall validation strategy on what would be required for Commissioning, Validating and new facility start up developing IQ, OQ and PQ Protocols for their new facility and process manufacturing equipment. I also gave directions to management on Process Validation requirements under 21 CFR: Parts 210/211.

• Authored IQ & OQ. Protocols for qualification requirements for new facility, utilities and all construction activities to assure all GMP requirements were met prior to FDA inspection.

• The IQ and OQ protocols consisted of, facility description, type and size of the building, supporting utilities such as rooftop HVAC units, Electrical system and all components, Compressed air system, As Built Drawings, P&ID diagrams, Facility Lighting, etc. I also instructed several training sessions for in-house employees on proper execution of these protocols.

RICHARD KISER Page 3 of 5

• Instructed Management on how to set up a new document control department for tracking documents so they could assure and maintain Good Document Practices.

• Outlined in the Master Plan what is required in an Engineering Design History File for any future new devices or to any changes made to their existing devices.

FORT DODGE ANIMAL HEALTH / Fort Dodge, Iowa (2005-2007), a division of Wyeth Pharmaceuticals Inc. Project Lead Person

• I was the Project Lead for a new Automation Building Management System (BMS) for HVAC controls. This involved changing over 23 HVAC units from an existing 20 year old Staefa system to a new Johnson Controls system. This was a major C A P A project at a cost of One-Point-Two Million Dollars ($1.200,000.00). This was mandated by the FDA for process validation for the company’s manufacturing areas and aseptic filling suites.

• My responsibilities for this project were to oversee all changeover activities from an existing Staefa Control system to a new Johnson Controls, Inc. Control system. I was responsible for over seeing all installation and Validation activities on a daily basis with Johnson Controls, Inc., Electrical Contractors and In-House personnel. This involved installing new Control Panels, new Control Cards, Re-Heat Coils, Freeze Stats, Bubble type Dampers, Zone Temperature Controllers, Humidifier controllers for controlled areas, new Setras, Allen Bradley Process Logic Controllers (PLSs), Critical and Non Critical alarms. There were 9 new Computers installed consisting of Engineering Workstations that were password protected, Monitoring Workstations and (OITs) Operator Interface Terminals.

• I Authored a User Requirements Specification Document (URS), for the BMS to include the functionality of the system for controls and monitoring activities. The URS document also defined the system requirements necessary for network communications, human-machine interface (HMI), printing, archiving, and hardware/software platforms. The scope of the URS is limited to defining the requirements for the network, servers, workstations, and controllers. Microsoft Windows 2000 operating system was utilized for all computer systems. The servers were loaded with the applicable vendor application software, 21 CFR Part 11/Annex11 OPC compliant. I also wrote IQ,OQ and PQ protocols for this new system.

• Attended weekly project status meetings to keep management informed of the progress and activities during the course of this project and other projects I was involved in.

JOHNSON & JOHNSON / Puerto Rico 2004 - 2005

• I was a Project Lead Person performing FAT testing on four large 30 shelves Lyophilizes. My responsibilities were to verify that all As-Built drawings for mechanical, electrical and control wiring drawings were certified.

• Validated the environmental chamber, including the verification of utility flow, pressure checks, and temperature monitoring using a Kaye Validator 2000. Verified all critical controlling instrumentation such as Allen Bradley Process Logic Controllers (PLCs) had been calibrated prior to execution of the FAT and were supported with a calibration certificate. Performed a complete check of the electrical systems and all wiring schematics.

• Verified and obtained the appropriate weld maps, certifications, and videotapes and preformed a 10% check of the welding log.

RICHARD KISER Page 4 of 5

SANOFI PHARMACEUTICAL / Pennsylvania 2004

• I Developed Project Validation Plan for a new class 100,000 Aseptic Suite that was being constructed with equipment and supporting utilities.

• In the validation plan I defined validation requirements for supporting utilities such as, chilled water, purified water, clean steam, plant steam, medical grade nitrogen, and compressed air.

• Defined validation requirements for High Potency Suite Airlocks and Air Flow including HVAC, HEPA filters and hourly air changes. Also Environmental Monitoring, an Interim Project Commissioning Checklist, Material Flow, Cleaning Deviation review.

• I authored IQ, OQ and PQ protocols for an Isolation Barrier for a new Aseptic filling line and a Kuhlman Autoclave. I also participated in executing these protocols.

SCHERING PLOUGH / New Jersey 2002

• I Worked on Critical Utilities that were mandated by order of a FDA Consent Decree. Wrote new Operational Qualifications for Re-Validation on the following systems: CIP, Compressed Air, Nitrogen and HVAC.

• Wrote Maintenance SOP’s for the CIP Cleaning and HVAC Systems addressing pumps, heat exchanger gasket and seal replacement, Pre Filters, Final Filters, HEPA Filters Fans and Fan motors. Also wrote some Assessments on what would be required for compliance on some of the utilities.

PHARMACIA / Michigan 2001 - 2002

• My responsibilities were to write a validation plan, an IQ. And OQ. Protocols along with overseeing proper test procedures were implemented for the execution phase for a re-validation project on a Sterile Packaging Line and Despatch Oven. This was Class lll Medical Device product for surgical sponges used in human surgery to stop excessive bleeding.

• I worked with the Engineering department for the installation of a new Chilled Water system for the manufacturing area.

• Assisted the Controls Engineers for proper placement of PLC’s, and a new Control Panel to be installed for manufacturing processes...

• Reviewed all IQ and OQ Equipment protocols along with critical utilities protocols.

• Prepared Final Reports along with addressing any Deviations that occurred during the execution phase.

GENETICS INSTITUTE / WYETH / Massachusetts 2000 - 2001

• Project Lead Person for Clean-in-Place (CIP) replacement project. Worked with in-house Validation, Manufacturing, and Engineering departments addressing Conductivity, TOC and, Phosphate issues with their CIP system.

• Preformed engineering study on the complete CIP system and CIP Skid with Transfer Lines, Buffer Tanks, Media Tanks and Bio-Reactors. Defined validation tests to verify and document the ability of the cleaning programs to re-move test solutions from vessels and transfer lines. Also worked on protocol writing, review, and re-validation assessments for a CIP new system.

RICHARD KISER Page 5 of 5

BAXTER HEALTHCARE / Thousand Oaks Facility, California 1999 -2000

• Project Lead, of 5 contractors, my responsibilities was to author IQ, OQ, & PQ Protocols for process equipment and critical utilities for a new Cell Culture production area. I was also responsible for overseeing the execution phases of these protocols.

• Equipment included Autoclaves, Media Tanks, Bio-Safety Cabinets, Incubators, Buffer Tanks, Depyrogenation Oven, Parts Washer, Harvest Carts, Centrifuges and Systems-CIP, SIP, WFI, Glycol and Clean Steam. Oversaw the installation of new equipment along with supporting utilities.

• I was responsible for completed final technical review that all Protocols were properly and fully executed. Addressed deviations that occurred during the execution phase were true deviations and were properly written and justified.

EDUCATION:

BSME Engineering

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