​​​​Jonathan Kusselson

Emergent BioSolutions, Rockville, MD

Validation Engineer                                                                                                        December 2021 – Present

• Performing annual revalidations on production equipment including the Telstar lyophilizer, isolators, and Lytzen oven.

• Plan, coordinate, and execute assigned projects using project management methodologies. For example, Validation lead on QC Analytical and Microbiology equipment (density meter, FTIR, headspace analyzer, endotoxin analyzer, sterility pump, bioburden pump, NVP/NPC, Viable air sampler, and various controlled temperature units)

• Create and execute commissioning, qualification protocols, and validation protocols and plans (CX/IQ/OQ/PQ), including identification and resolution of non-conformances consistent with site procedures and practices.

• Reviews and approves technical documentation including system lifecycle design documentation (user requirements, risk assessments, data integrity assessments, qualification protocols, summary reports, and trace matrices).

 

PCI (formerly Lyophilization Services of New England (LSNE)), Madison, WI

Validation Engineer                                                                                                        December 2019 – December 2021

• Generated/Revised/Executed installation, operational, and performance qualifications (IQ/OQ/PQ) for vessels/tanks/mixers, IVEK filling system, controlled temperature chambers (CTCs), Secure Desktop and Acronis software and enVigil facilities monitoring system.

• Generated/Revised/Executed autoclave performance qualifications (sterilization and/or bioburden reduction) for specific client load configurations as well as autoclave requalifications (RQ) – empty chamber sterilization and filter sterilization.

• Assisted the planning, preparation, and execution of qualifications for the internal and external vial washer, depyrogenation oven, and lyophilizer SIP system.

• Experience using the Kaye Validator 2000, Kaye AVS, and Kaye ValProbe systems for temperature mapping, report generation and statistical analysis.

• Experience identifying, investigating, and determining root cause of validation equipment issues and qualification deviations/discrepancies.

• Written and revised final reports of qualification work.

• Experience writing risk assessments to evaluate the severity, probability, and detectability of a failure.

• Knowledge of ISPE, PDA, and USP guidelines governing validation best practices.

• Assisted with the execution of smoke studies and documentation of airflows and operator interventions in an aseptic environment. This included the video documentation of static and dynamic testing and interventions by operations personnel.

• ISO5 gowning qualified with requalification every six (6) months.

• Experience with a client specific process validation including but not limited to exposure to a FMEA, CPPs, CQAs, product sampling (in-process and final product).

• Experience supporting and assisting management with client audits, audit responses, and information requests by regulatory agencies.

• Managed project from the project scope phase to completion and approval of final reports to decommission, requalify or initially qualify eighteen (18) CTUs.

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Illumina, Madison, WI

Validation Coordinator (Contractor)

​January 2019 – June 2019

• 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.

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PPD, Middleton, WI

Facilities Coordinator (Contractor)

​October 2018 – January 2019

• 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.

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Illumina, Madison, WI

Facilities Compliance Coordinator (Contractor)

​October 2017 – September 2018

• 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 regulations.

• 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.

• Collaborated with other teams at other sites to exchange facilities and compliance best practices including the development of the 3rd party/outside vendor training program.

• Communicated with the Facilities maintenance team to address the quality of work order documentation and correct documentation deficiencies prior to work order closure.

• Performed internal dept audits of records (i.e equipment records, vendor training logs, etc.) to monitor for compliance.

• Maintained Facilities Department compliance through CAPAs and NCRs.

• Worked on cross functional teams (with OPS and QA) to initiate, perform risk assessments, investigate, and implement Corrective Action, Preventative Action (CAPAs) and Non-Conformance Requests (NCRs).

• Conducted and determined root cause analysis for Facilities CAPAs and NCRs. (i.e. 5 Whys, Fishbone, etc.)

• Facilities change control (FCC) program process owner.

• Created, updated, and executed SOPs through SAP for facilities owned processes and equipment.

• Collected and completed documentation for Quality Plan deliverables.

• Maintained facilities processes for audit readiness and provide support for internal, customer, and regulated body audits and inspections (e.g. FDA-21 CFR 820, ISO-13485, etc).

• Support, comply and improve the 6S (5S+Safety) program as 6S area lead.

• Collaborated, supported and provided consultation for site process improvement projects including improving the Kanban process for the Purification Department.

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Utilization Management Tech

​December 2016 – September 2017

• 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

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Tax Representative

​January 2016 – August 2016

• Reviewed taxpayer data for compliance with state laws, statutes and regulations.

• Composed letters informing taxpayers of their non-compliance and requesting taxpayers re-submit forms and/orupdate their records.

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Team Project - Student Consultant

​January 2015 – May 2015

• Developed surveys for employees to identity strengths and weaknesses in the workforce and workforce processes.

• Identify patterns in the results, provide recommendations and supporting action steps for enhancing the effectiveness and performance of their workforce.

• Applied the Workforce Focus aspect of the Baldrige Performance Excellence Model to the restaurant as well as applied team development concepts learned in lecture.

 

Maintenance Planner/Scheduler

June 2013 – August 2014

• Develop work plans and schedule plant maintenance in a cost effective way while maximizing labor resources.

• Manage the JD Edwards/Catalyst/E1 maintenance work order system; prioritize maintenance work, add assets to system, updating and scheduling preventative maintenance work.

• Analyze, update and present KPIs for Superintendent and plant manager on a weekly basis.

• Perform safety audits on departments in the facility and participate in Safety Stand-Down.

• Coordinate with project engineers on the final planning and implementation of safety projects.

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Maintenance Supervisor

December 2011 – June 2013

• Lead a team of nine maintenance mechanics by planning and organizing daily plant maintenance tasks.

• Troubleshoot equipment causing downtime with team to efficiently locate and repair equipment problems.

• Ensure 100% preventative maintenance compliance per department directive and that corrective maintenance was completed in a timely manner.

• Initiated, planned, and executed continuous improvement projects to relocate motor inventory.

• Make quick business oriented decisions taking into account the safety, costs, technical complexities, resource limitations, operational dynamics, quality, OSHA regulations and union contract, and GMPs.

• Managed a project designed to eliminate a slippery work area that had become a safety hazard.

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Quality Assurance Engineer

October 2010 – December 2011​

• Comprehensively test applications and software on cellular devices, iPads, iPhones, and PCs.

• Detect, reproduce, and report bugs, issues, and concerns about an application’s functionality, user interface,connectivity, and device/application interaction.

• Perform adhoc analysis and extensive testing on new android devices on Verizon’s new 4G/LTE network.