Computer System Validation, Equipment Qualification Expert Consultant ResumeThis expert specializes in equipment / systems, utilities and facilities qualification/validations and manufacturing.
Areas of experience include computer system validation, validation engineering, manufacturing equipment qualification, facility and utility qualification, project engineering and management.
Validation and compliance experience covers coordination, leadership and qualification (IOP / Q) as well as commissioning. This expert is experienced in coordinating the validation and installation activities with other consultants, engineering firms and construction contractors.
Consultant, Kevin Kennedy Associates Inc.
Providing expertise in equipment / systems, utilities and facilities qualification / validations and manufacturing, and related expertise to a wide variety of clients.
Computer System Validation
Developed and implemented remediation strategy for twenty (20) out of compliance printer systems (Packaging area). Developed and implemented CSV remediation strategy for four (4) out of compliance diode laser systems (Manufacturing area). Assessed and remediated activities for electronic labeling system that provided access to electronic instructions for use and labeling information of medical devices. Reviewed SLC documentation for compliance with regulations, which included development of new validation deliverables as part of the assessment and remediation activities. Developed and executed IQ/OQs for process control systems (bioreactors). Executed and revised compression area validation documents (IQ/OQ): Double-sided Tablet Press system including automated PLC Control System.
Validation / Engineering
Supported/coordinated functional and operational (OQ) tests as part of qualification activities of new API area (Duloxetine). Reviewed qualification packages for new API area. Coordinated IQ phase activities for Accela-Cota Coating system, Coating Spray System, Air Handling Unit and Compu-Coat Control System. Generated IQ/OQ protocols for new and existing duloxetine hydrochloride process areas: including HCl acid delivery systems and process tanks. Generated IQ/OQ protocols for Purified Water and Delta V Control System. Generated/executed IQ protocols for equipment, instrumentation and processes for new API building facilities. Coordinated validation documentation activities: red-line of P&IDs, determined validation project boundaries (modules) & updated Validation Project status database (Microsoft Access). Generated Validation Master Plans.
Manufacturing Equipment Qualification
Executed SAT documents / performed SAT activities for manufacturing equipment. Generated IQ/OQ/PQ protocols for mechanical equipment and production lines for nicotine gum building facilities. Executed OQ/PQ documents for parenteral areas, which included: Vial Washer Machine, Sterilization Tunnel, Filling/Stopper Machine and Formulation Process with CIP Skid. Qualified Finn-Aqua® Steam Sterilizer (OQ/PQ) as part of parenteral area modifications: Temperature Distribution and mapping studies (Kaye Validator).
Facilities/Utilities Qualification
Generated and executed IQ/OQ/PQ and commissioned documents for HVAC systems of Manufacturing Areas. Responsible for assessing and remediation activities for HVAC control system. This activity included evaluation of deliverables, regulatory requirements, and company standards. Executed HVAC validation documents (IQ/OQs) for Mechanical and Control System (packaging line).
Project Engineering
Performed preventive maintenance and inspection of boiler's fireside, valves, combustion chamber, and replacement parts. Provided project management support during new chemical plant qualification (API facilities), direct interface with client & construction personnel.
Project Management
Scheduled meetings with management, research documentation, and summary memos reporting findings (gaps) in compliance with the remediation strategy. Led P&ID training of validation consultants. Supervised and supported chemical and mechanical projects.