Consultant, Kevin Kennedy Associates Inc.
Providing expertise in commissioning and qualification engineering, equipment / systems, computer system validation (CSV), utilities and facilities qualification / validations, manufacturing, packaging, and related expertise to a wide variety of clients.
Commissioning & Qualification Engineer II, Genentech, Vacaville Site, CA
Materials of Construction Assessment and Verification: Reviewed the construction Turn Over Packages (TOP's) to ensure all product contact lines and equipments were properly certified as the material required for the process. Reviewed the P&ID drawings against the Weld Maps and Isometrics drawings to verify that the lines, valves, instruments, and equipments were properly and accurately tagged. Documented all the findings on a spread sheet along with heat numbers for the lines, fittings, product contact instruments and equipments, as well as specific details for material and contact surface finish. Verified that if no material certification was provided on the TOP for any given part, a Positive Material Identification (PMI) test was available for the part. Control Qualification Review: Reviewed and verified the executed tests for the Control systems from the Supplier Acceptance Test (SAT) and Factory Acceptance Test (FAT) to the on site start up and debug and Installation Qualification. Reviewed the Traceability Matrix for the testing performed as well as the Summary Reports for each section of testing. Revalidation, Validation and Qualification: Developed the documentation and testing required to verify the validated status of the Clean Steam Utility, Heating Hot Water Utility, Air Handling Units, and Plant Steam to demonstrate the continuous efficacy of the systems. Developed the documentation and testing required to verify the validated status of the fixed and portable tanks to demonstrate continuous efficacy of the steaming procedures for sterilized process tanks, via Steam-In-Place (SIP) testing.
Commissioning and Validation Consultant, Brischem Reyataz Capability Project, Bristol - Myers Squibb, Barceloneta Site, Puerto Rico
Performed start-up for new Building Management System (BMS). Assigned to coordinate the project activities as leader for the HVAC system. Performed the systems SOP's, and coordinated the technicians for repairs and troubleshooting.
Consultant, Cordis Johnson & Johnson, CNV & Miami Sites, Miami Lakes FL
Was responsible for audit of Computer System Validation documents for the Cordis Johnson & Johnson manufacturing systems. Responsible for performing System Assessment Checklist for retrospective evaluations of Computer Systems used on Manufacturing of medical devices (Balloons, Catheters, etc.), to ensure that regulatory requirements, such as Johnson & Johnson Standards, Cordis Standards, US FDA's 21 CFR Part 11 regulations, FDA's 21 CFR 58, 820, 210, and 211 regulations, and EU Annex 11 were met. Performed a Risk Assessment analysis to identify any gaps and develop a Corrective Action Plan. Developed and approved a Change Control Request to delineate the remediation activities and requirements for the systems. Was responsible for the development and execution of the Remediation Plan to solve gaps found on the Risk Assessment Analysis. Responsible for the development and execution of any document required to demonstrate a validated status for the system such as Validation Strategy, Equipment IQ/OQ's, Software IQ/OQ's, System and User Requirements Specifications, and Traceability Matrix documents. Was responsible for the development and approval of the Corrective Action Closure Form, along with the Closing Report for the remediation activities.
Validation Scientist, Tiazac and Diltiazem ER 14 Process Transfer Project, Biovail Laboratories Inc., Dorado Puerto Rico
Was responsible for the assessment of the different utilities (Compressed Air, Vacuum, Negative Exhaust, and Deionized Water) to assure qualification status and compatibility with the process transfer from Biovail Carolina PR site to Biovail Dorado PR site. Responsible for the generation and execution of process, coating, encapsulation, and packaging qualification and validation protocols for the process transfer. Responsible for the development of the validation master plan that will delineate the process transfer. Preparation and execution of Special Studies conducted to establish operational parameters.
Validation Scientist, Amgen Manufacturing Limited, Juncos Puerto Rico
Responsibilities included assessment of the different equipment and tanks used for the production of Enbrelto assurance that these were included in the AML Periodic Monitoring System. Was responsible for the generation and execution of Periodic Monitoring documents (Clean in place and Steam in place) for process tanks. Also responsible for the generation of the Periodic Monitoring Final Report documents (Clean in place and Steam in place) for process tanks.
Validation and Compliance Specialist, Schering Plough Products LLC, Manati, Puerto Rico
Project: Control Support Systems Responsibilities included the assessment of the different utilities (Compressed Air, Nitrogen, Vacuum, Negative Exhaust, Solvents, Soft Water, and Deionized Water) of the Pharmaceutical, Netilmicin, and Steroids
Chemical Plant. Audited the existing Qualification and Validation documentation to identify gaps and develop a remediation plan. Was responsible for the generation and execution of remediation projects for the different utilities (Compressed Air, Nitrogen, Vacuum, Negative Exhaust, Solvents, Soft Water, and Deionized Water) of the Pharmaceutical, Netilmicin, and Steroids
Chemical Plant. These assessments, remediation, and all the reports generated were part of the actions agreed in the Consent Decree of Permanent Injunction. Other duties included Preparation & Execution of Technical Reports, Engineering Studies and Performance Reviews for the different utilities (Compressed Air, Nitrogen, Vacuum, Negative Exhaust, Solvents, Soft Water, and Deionized Water), Preparation and Execution of Qualification (IQ, OQ, and PQ) Protocols and Commissioning Documents related to utilities equipment for the steroids plant related to Deionized Water (DI) generation and distribution utilities, and Soft Water generation and distribution utilities, revision and development of Operation and Maintenance SOP's, and revision and updating of process and P&ID drawings for API Steroids and Netilmicin plants.
Project and Validation Engineer, Pfizer Pharmaceuticals, Barceloneta site
Responsibilities included development of validation protocols for facilities qualification and air handling units qualification, and clean room certification for the TPM 11 manufacturing module and installation and operational qualification for the HVAC system serving this module (AHU-7). The certification for this module included Facilities Qualification and Utilities Qualification (Hot and Cold Water, Compressed Air, Nitrogen, House Vacuum, Explosion Prove Power Outlets, Electric Circuits, and Breathing Air). Clean Room Certification for the Compounding Milling Facility and Installation and Operational Qualification for the HVAC system serving this facility (AHU-9). The certification for this Compounding Milling Facility included Facilities Qualification and Utilities Qualification (Hot and Cold Water, Compressed Air, Nitrogen, House Vacuum, Explosion Prove Power Outlets, Electric Circuits, and Breathing Air). Conducted Testing and Air Balancing, Static Ambient and Dynamic Ambient Tests, following Pfizer requirements for the HVAC qualifications performed.
