pharmaceutical, biotechnology, qualification, validation expert consultant resume
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Resume of DPS Consultant
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  • Pharmaceutical
  • Biotechnology
  • Medical Devices

This expert attended the University of Puerto Rico, Mayagüez Campus and received a B.S. in Chemical Engineering (BSCE) from that university.

Pharmaceutical, Biotechnology, Qualification, Validation Expert Consultant Resume

This consultant offers specific experience relative to the pharmaceutical, biotechnology, and medical devices industries.

This consultant has experience in equipment /systems, utilities and facilities qualification /validations and manufacturing.

This consultant’s validation and compliance experience includes coordination, leadership and qualification (IOP/Q) as well as commissioning.

Additional experience and specialization of this expert includes coordinating the validation and installation activities with other consultants, engineering firms and construction contractors.

Consultant, Kevin Kennedy Associates Inc.

Providing expertise in chemical engineering, utilities and facilities qualification /validation, pharmaceutical, biotechnology, and medical device consulting, equipment /systems, and related expertise to a wide variety of clients.

 

Computer System Validation Consultant

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 that 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 Consultant

Supported /coordinated functional and operational (OQ) tests as part of qualification activities of new API area (Duloxetine). Reviewed of 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 Consultant

Executed SAT documents / performed SAT activities for manufacturing equipment. Generated IQ/OQ/PQ protocols for mechanical equipment and production lines for Nicorette® Gum building facilities (nicotine gum). 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 Consultant

Generated and executed IQ/OQ/PQ and commissioned documents for HVAC systems of Manufacturing Areas. Was 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 Consultant

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 Consultant

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.

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FEATURED CONSULTANT

Peter Habicht, Lead Consultant
Peter specializes in welding and metallurgical engineer with 40 years industry experience in commercial nuclear power plant construction.

CONSULTING OPPORTUNITIES

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