Validation of Pharmaceutical Manufacturing and Research Facilities Expert Consultant Resume
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Resume of BCT Consultant
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  • Pharmaceutical
  • Environmental

This expert received a B.A. in Biology and in Environmental Science from Thiel College in Greenville, PA.

Validation of Pharmaceutical Manufacturing and Research Facilities Expert Consultant Resume
 

This expert has diversified experience in the validation of pharmaceutical manufacturing and research facilities, cGMP/GLP compliance applications, quality management systems and construction project management. This expert is effective in developing quality management systems based on a pragmatic approach. Expertise of this consultant includes business management team leadership and communication in a fast-paced changing environment.

Consultant, Kevin Kennedy Associates, Inc.

Provides expert consulting services in the validation of pharmaceutical manufacturing and research facilities.

Acting Director, Facilities Management & Engineering (FM&E), Global Research and Development for Major Pharmaceutical company, Ann Arbor, MI

Key responsibilities include directing daily facilities operations including Powerhouse utility operations, building maintenance and repair, renegotiating vendor services, equipment maintenance and repair, and ensuring compliance with policies, procedures and regulations. Assist departing colleagues with their transitional plans. Implement the Decommissioning Plan for buildings as they are emptied and make revisions accordingly. Develop transition plans from previous organizational structures to support ongoing facility operation.

Associate Director, Facilities Management & Engineering (FM&E), Facilities Validation), Global Research and Development for Major Pharmaceutical company, Ann Arbor, MI

Responsible for facilities validation and GxP compliance. Acting as compliance lead for global computerized facility management (CFM) system. Liaison for Global Operations during regulatory audits of the Ann Arbor site, and global inspections of CFM. Assisted other PGRD facilities groups in establishing quality systems. Global Operations Quality Compliance Lead for the GO Live facilities management system installation and validation. Participated in the load sharing of FM&E management needs by assuming responsibility of facility maintenance. Responsible for facility maintenance and validation budget development and spending.

Senior Project Manager, Facilities Management & Engineering, Facilities Validation), Global Research and Development for Major Pharmaceutical company, Ann Arbor, MI

Responsibilities included, in addition to facilities GxP compliance, the management of the Technical Development Facility (TDF) Building Program for both construction and facility validation. Management of: project planning, budget, schedule, construction, commissioning and validation of critical facility systems. The project size was approx. 425,000 SF with a total budget of approximately $250 MM. Assisted with coordinating an overall project schedule for the entire site expansion project for the Ann Arbor site, management of other projects that were required for the TDF building. Coordinated the Owner Controlled Insurance Program for the major expansion building projects at the site. Managed and continued to enhance the site GxP quality management program.

Project Manager, Engineering, Global Research and Development for Major Pharmaceutical company, Ann Arbor, MI

Developed and coordinated the first site facility engineering quality system for GMP/GLP compliance at the Ann Arbor site. Included the departmental SOP system, training tracking system, validation protocols and change control system, audits and responses, and maintenance tracking system administration. Supported the GMP/GLP initiatives of other departments as required. Initiated the preliminary building design studies for the Technical Development Facility project.

Senior Validation Technologist, Parke-Davis Sterile Manufacturing, Rochester, MI

Responsible for generating and executing validation protocols for new equipment and systems, including aseptic processes, HVAC systems, WFI and RO systems, filling equipment, capping/packaging/inspection equipment, terminal sterilizers, and laboratory equipment. Completed projects independently and designed qualification test functions and coordinated validation of integrated processing systems. Participated in audit functions with contract manufacturers. Evaluated and resolved manufacturing problems and directed activities of department co-operative students.

Validation Technologist, Parke-Davis Sterile Manufacturing, Rochester, MI

Wrote and executed validation protocols for sterile production equipment and associated critical utilities. Equipment included steam and water spray sterilizers, dry heat depyrogenation ovens and tunnels, Filling and Packaging equipment.

QC Validation Supervisor, Fujisawa Pharmaceuticals, Grand Island, NY

Established the first formal validation/calibration department for this sterile manufacturing facility. Participated in FDA Consent Degree activities at Fujisawa giving me greater insight into cGMP requirements for pharmaceutical facilities. Supervised Associate Scientists in the validation of aseptic filling, sterilization, packaging, and analytical processes. Supervised technicians in calibration of all critical instrumentation within the facility and established in-house Metrology programs. Developed the Validation Master Plan for the Grand Island site. Assisted in the development of corporate validation and quality policies. Assisted in developing the site Drug Master File Aseptic Fill Program and Terminal Sterilization Program. Conducted audits ranging from site Master Batch Records for compliance with NDA filings to contracted vendor services. Member of the site Validation Project Committee and the Validation Department Operating Budget

QC Microbiology Scientist, Fujisawa Pharmaceuticals, Grand Island, NY

Responsible for monitoring and testing of sterile SVP products for compliance with federal cGMP’s and USP testing requirements. Validated equipment and systems, including aseptic processes, HVAC systems, WFI and purified water (RO) systems, filling equipment, compounding systems, sterilization systems, environmental monitoring systems, and microbiological control programs. Supervised daily activities of Associate Scientists.

Microbiological Laboratory Technician, SUNY, School of Medicine and Dentistry, Buffalo, NY

Provided anaerobic microbiological and clinical data to Research Scientists.

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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.

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