Jonathan K. Email & Phone Number

Gaithersburg, Maryland, US

• Performing annual/biannual/triannual revalidations on bio process production equipment in an FDA regulated clean room environment (lyophilizer, isolators, sterilization/depyrogenation oven, and rotary washer).
• Validation project leader managing all aspects of the Validation lifecycle for QC Analytical and Microbiology equipment (user requirements, vendor and supplemental qualification protocols, summary reports, and trace.
• Review and approve documentation from all aspects of the Validation lifecycle.
• Author and execute commissioning, qualification protocols, and validation protocols and plans (IQ/OQ/PQ), including identification and resolution of non-conformances consistent with site procedures and practices.
• Troubleshoot and resolve a wide range of complex issues related to equipment qualifications and computer system validations.
• 2+ years of experience with QMS, Veeva, asset management software SAP, and project planning tool Smartsheet.

Philadelphia, PA, US

• Generated/Revised/Executed IQ/OQ/PQ for vessels/tanks/mixers, IVEK filling system, CTCs, Secure Desktop and Acronis software and enVigil facilities monitoring system.
• Revised/Executed autoclave PQs (sterilization and bioburden reduction) for client load configurations as well as annual autoclave RQs.
• Planned, scheduled, coordinated, and executed qualifications for the production line’s internal and external vial washer, depyrogenation oven, and lyophilizer as well as QC equipment: viable air samplers.
• SME of the Kaye datalogging equipment (Validator 2000, Kaye AVS, and Kaye ValProbe and respective datalogger software used for temperature mapping, report generation, and statistical analysis.
• Validation project leader managing an initiative to increase CTC capacity for Supply Chain and QC. Eighteen units decommissioned or initially qualified.
• Experience identifying, investigating, and determining root cause of validation equipment issues and qualification deviations/discrepancies.

San Diego, CA, US

• Support the creation, revision, and execution of commissioning documents such as Performance Qualifications (PQ) and Installation/Operation Qualifications (IOQ) for new equipment.
• Control, track, and monitor commissioning and related validation documents from creation to secure document storage.
• Track validated, calibrated, and “plug and play” equipment as a part of Quality Plan deliverables.
• Investigate, and implement Non-Conformance Requests (NCRs) related to relocated equipment.

Wilmington, NC, US

• Receive chemicals, reagents, buffers and other necessary testing materials in accordance with PPD internal standard operating procedure (SOP).
• Perform building and equipment maintenance tasks including the completion of work orders, schedule routine and preventative maintenance, and repairs.
• Create and develop workflows for facilities processes for use as job aids.
• Coordinate the purchase of supplies and manage stock inventories.

San Diego, CA, US

• Created, developed and maintained facilities processes in accordance with FDA-21 CFR 820.
• Managed the Illumina-Madison Advanced Maintenance Management System (AMMS) work order system that had over 150 pieces of facilities equipment and ensured their compliance with internal SOPs as well as with external.
• Added/Changed/Deactivated facilities assets in AMMS, wrote preventative maintenance (PM) tasks, and created PM schedules.
• Created and developed workflows for facilities processes in accordance with internal Illumina SOPs for use as job aids.
• Created and developed an on-boarding program for new maintenance team members.
• Managed and maintained 3rd party/outside vendor service records and training records.

Madison, WI, US

• Submitting inpatient & outpatient authorizations into MetaVance for all DHP products.
• Function as a liaison to other departments regarding work flow and responsibilities of UM activities.
• Compiling error reports for authorization with contradictory information

• Reviewed and validated over a 100 taxpayers a day for compliance with state laws, statutes and regulations.
• Utilized the Wisconsin Income and Tax Processing System (WINPAS) to validate taxpayer submissions and correct some taxpayer information.
• Wrote letters to taxpayers in non-compliance to resubmit forms and/or update their personal records.

Arden Hills, Minnesota, US

• Prioritized maintenance work based on criticality of equipment to production and plant operation.
• Coordinated with production departments and maintenance supervisors to schedule maintenance during downtime -saved the company $5,000/mo.
• Compiled, analyze and reported Analyzed Key Performance Indicators (KPIs) that were presented in weekly meetings to upper management.
• Planned round-the-clock maintenance work for major plant shutdowns.
• Scoped out maintenance work orders, developed maintenance work plans, ordered parts from suppliers, and estimated employee hours.
• Communicated weekend plans and schedules to all three maintenance shifts.Trained by the Marshall Institute on Planning & Scheduling and by Franklin Covey on Project Management.

Arden Hills, Minnesota, US

• Lead, coached, and managed a team of 9 maintenance mechanics by planning and organizing daily maintenance tasks.
• Troubleshooted equipment with team to efficiently locate and repair equipment problems.
• Ensured that all preventative maintenance (PMs) were completed in a timely manner and in compliance.
• As a safety committee member, performed safety audits on 4 departments a month to improve safety awareness and identify safety deficiencies throughout the plant.
• Initiated, planned, and executed 3 continuous improvement projects. One of which was a project to relocate inventory.
• Managed a project designed to increase safety to replace and rebuild work area decking.

London, GB

• Tested applications on smartphones and tablets according to established testing procedures and procedures specifically developed for the application.
• Detected, reproduced, and reported bugs, issues, and concerns about an Apps functionality, user interface, connectivity, and a devices user interaction by following well established test plans.
• Performed ad hoc analysis and extensive testing on new android devices on Verizon’s LTE network.

• Produced assembly drawings of conveyor systems for project engineers using AutoCAD.
• Produced specialized drawings for machined parts using Geometric Dimensioning & Tolerancing standards.
• Supervised the assembly of several conveyor systems.

• Designed conveyor/automation systems with AutoCAD for clients in collaboration with the applications engineer and salesman for estimation purposes.
• Tested client products on Flexlink conveyors to determine practical conveyor solution.
• Presented conveyor system bid information to the project engineering department.

Bachelor Of Science, Mechanical Engineering

Professional Development, Construction Management