Jonathan M. Email & Phone Number

Durham, North Carolina, Us

Ingelheim Am Rhein, Rhineland-Palatinate, De

2016 (APRIL) to presentProject Manager for NAM Cleaning ValidationFor two North American Facilities lead the initiation of cleaning validation for process equipment for all of Operations. Position reports to the North American Quality Assurance Head. CQV Specialist in QA for New Equipment, Change introduced qualification, Change Control SME Sterilization and Cleaning Processses, Trackwise CC and CAPA.2012 to 2016 (SEPT) Vaccine manufacturing and filling company. As a representative of the Quality Assurance department, the Specialist performs the following required activities below:• Perform criticality assessments for initial validation/ qualification based on the Company Global Quality standards and regulatory requirements.• Develop and document the process and project Validation Master Plans (VMPs).• Plan and structure validation activities for facilities and equipment in coordination with ENG/ Client PMs.• For hard asset capital projects, develop RFP, review proposals, procurement of outside consulting firms, supervise and manage execution of CQV activities.• Attend and monitor execution of Factory Acceptance Testing at supplier’s site, when necessary.• Ensure that the validation activities identified in the VMP are implemented and documented through protocols for design, installation / operational, software, and performance qualifications.• Develop a project Validation Master Report (VMR) at the end of the project to summarize the qualification / validation executions, deviations, and conclusions.• Develop IOQ, PQ, Media Simulation / Fill, and Process Validation protocols or review and audit protocols created by suppliers and consultants. • Responsible for hands-on training and development of manufacturing capability in execution of qualification / validation.• Responsible for the development of in-house procedures identifying the requirements of qualification / validation to align with global procedures and regulatory requirements.

Soccer Official for Top Amateur to Youth, High School, and College Soccer.

Waltham, Ma, Us

Manage Validation Lab Specializing in Factory Acceptance Testing of Refrigerators, ULT Freezers, Cryogenic Freezers, Incubators, Ovens, Centrifuges, and other seperations devices. Role included a Quality function for the High Performance refrigeration product line as Customer Focused Improvement Team Leader, Internal ISO Lead Audtor, and Management of the Quality Sampling Plan for Ultra Low Temp and HP Refrigerator Products. Role supervised the Calibration/Metrology program consisting of 1100 gages used in the factory and in North American Field Service. I supported internal and external testing requests on products with results and data to include new products and RMA analysis. Also worked closely with Quality Engineers to identify and correct non-conforming material for all product lines.Skills and TrainingLab Management, Validator 2000, Refrigeration including cascade type, Internal Lead ISO Auditor 9001 and 13485, Sound Level Testing, Non destructive sonic testing, Universal CFC.

Bachelor Of Engineering - Be, Chemical Engineering

Chemical Engineering