Jackie Somadelis

Experience

• 

  Bristol-Myers Squibb, Devens, Massachusetts

  Jun 2009 - Dec 2009

  Manufacturing/Validation Engineer, Co-Op

  • Collaborated with multiple functional groups to support the construction & validation of a $750M, 80+ acre, large-scale biopharmaceutical manufacturing facility• Supported IQ/OQ/OP equipment qualifications, IV/OV procedures under GEP and cGMP in addition to performing IQ/OQ/OP software qualification testing for DeltaV and Syncade with contract automation • Designed a user-friendly computer program that maps the entire biologics manufacturing process with all pertinent pipe networks and equipment from cell culture, process support, and downstream purification• Utilized Microsoft Visio linked to Microsoft Access with coding language, Visual Basic Editor, to enable all BMS employees to access equipment specifications and process parameters• Trained 50+ employees & senior management on program in multiple PowerPoint presentations Show less

• 

  Abbott Laboratories

  Jun 2010 - Aug 2010

  Manufacturing & Packaging Engineer, Intern

  • Outlined Project Management Plan under lean manufacturing practices to increase OEE (Overall Equipment Efficiency) in blister packaging process• Using problem solving & communication skills, developed vendor quotes for an Engineering Cost Estimate • Conducted financial analysis to determine Cost Avoidance, DCF/ROI, feasibility of capital investment• Prepared initial deliverables for an RCE (Request for Capital Expenditure) with projected annual savings of $346K in finished goods • Project Manager for multiple critical pharmaceutical manufacturing process/equipment improvements • Initiated Work Orders in Maximo to contract the installation of equipment & program modifications • Coordinated cleaning, equipment & software testing (IQ/OQ) under cGMP, GEP, and GAMP • Authored validation change requests and completed protocol packages into quality management system• Exhibited deliverables from packaging & manufacturing achievements in site-wide poster presentation Show less

• 

  Abbott Vascular

  Jun 2012 - Aug 2012

  Sterilization Engineer, Intern

  • Optimized electron-beam radiation sterilization processing & equipment for the ABSORB™ BVS (bioresorbable vascular scaffold) using advanced engineering, collaborative, and organization skills • Illustrated Project Management Plan and led weekly alignment meetings with multiple functional groups • Designed & executed R&D feasibility study to investigate the effect of new equipment on sterilization dose to product with FWT (Far West Technology) film dosimetry system, Genesis spectrophotometer and electron-beam.• Analyzed R&D data and previous dose maps to author engineering study protocol• Coordinated engineering study obtaining a sample size of 1000 dosimeter readings• Evaluated dose distribution, magnitude, and reproducibility with validated dose maps in Microsoft Excel and statistical significance in JMP software under International Organization for Standardization (ISO) regulations• Submitted 80-page supplemental validation report to improve the sterilization process by over 33% • Presented final results & implementation plan in 1-hour Microsoft PowerPoint presentation to entire Abbott Vascular R&D Division Show less

• 

  Interventional Spine

  Nov 2012 - Jan 2013

  Packaging/Sterilization Engineer, Consultant

  • Project manager for a Packaging & (Gamma) Sterilization Validation of a Class II, innovative spinal Medical Device using working knowledge of ISO 11607, 11737, 11137, 13485, 10993 & 9001• Developed Project Management Plan in Microsoft Project to estimate lead & turnaround time• Outlined test requirements, statistically valid sample plan & acceptance criteria in Microsoft Visio:o Packaging - Distribution Testing, Accelerated Aging, Packaging Integrity & Strength testingo Sterility: Sterility, Sterility Validation B/F Testing, Bioburden Testing & Recovery.• Negotiated packaging & sterilization validation testing price for cost savings of over 33% • Co-authored Special 510k submission for modification of the device from non-sterile to sterile• Ensured regulatory compliance under QSR 21CFR820, K90-1 Sterility Guidance, & Performance Testing Requirements• Led project transfer meeting in Microsoft PowerPoint to applicable personnel Show less

• 

  Applied Medical

  Jan 2013 - May 2015

  Sterilization / Process Development Engineer

  2015 - Process Development Engineer• Developed & Optimized Manufacturing Processes of Tissue Retrieval, Vascular/Urology Medical Device Systems• Initiated, authored, and reviewed Design History Files, phase development, hazard analyses, FMEA, document change requests), work orders, and design requirements• Authored protocols, defined robust test requirements & acceptance criteria in Microsoft Excel & Visio2013 - Sterilization / Process Development Engineer• Managed multiple process development projects related to the validation of a new high-power electron beam sterilization system with focus on designing Product Qualification activities of 300+ products• Managed the start-up & validation for the E-Beam Dosimetry Systems with cross-functional teams• Designed test requirements, documentation according to FDA quality system regulations, and statistically valid acceptance criteria considering uncertainty factors to validate the system.• Collaborated with packaging, regulatory, quality, & logistic teams in defining product families for dose map & process validation for in-house e-beam sterilization per ISO 11137, 11607, 11737, & 10993 Show less

• 

  Abbott

  May 2015 - Jun 2016

  Sterilization Engineer

  • Initiated, managed, and assisted concurrent process development projects to develop, maintain, and optimize sterilization processes of vascular, optical, and diagnostic medical devices using Electron-Beam Radiation, Ethylene Oxide gas, and Nitrogen Dioxide (NO2) gas.• Collaborated and innovated with cross-functional R&D, product development, and quality teams in devising new sterilization processes considering microbiology (bioburden) and sterility requirements• Defined test requirements and acceptance criteria to validate/verify sterilization process set-points and limits using technical knowledge and statistical data analysis with JMP software to ensure sterility and functionality of products/packaging systems at both on-site and off-site sterilization facilities.• Developed and supported manufacturing continuous improvement in all aspects of the production processes including operator operating procedures/training, materials management, tool calibration management, equipment and software functionality using lean manufacturing and analytical tools• Identified, investigated, and resolved non-conformances of products, materials, processes, and equipment related to sterilization processing utilizing CAPA methodologies while ensuring regulatory compliance (including but not limited to ISO 11135, ISO 11137, ISO 11607, ISO 14937) and documenting NCR’s (Non-Conformance Reports)• Authored, revised, and reviewed technical reports, validation/verification reports, and standard operating procedures per quality management system regulations (ISO 13485; ISO 9001) Show less

• 

  Johnson & Johnson

  Feb 2017 - Jun 2019

  Sterilization Scientist / Engineer II

  - Technical lead for multiple equipment sterilization validations/re-validations, implementations, and process improvements including Noxilizer RTS 360 system (Nitrogen Dioxide Gas), Getinge Steam Autoclave, and ASP VHP NX100 Sterilizer utilizing advanced technical expertise, exceptional project management (e.g. FPX) and team-work skills.- Lead and support operation, calibration, maintenance, and optimization of in-house gas & heat sterilization equipment including Ethylene Oxide (EO) Sterilizers, 3M benchtop EO sterilizer, Noxilizer RTS 360, Getinge GEV Steam Autoclave, Dry Heat, ASP VHP NX100 Sterilizer, Rees Scientific environmental monitoring system and et. al. ancillary equipment.- Lead and support global J&J sterility assurance franchises in new product development (NPD), packaging development/optimization and process development/optimization for medical devices, pharmaceuticals, and consumer products according to global J&J and international standards (ISO/AAMI).- Initiate, lead, and support quality non-conformance investigations, perform risk assessments, conduct root causes analyses, develop and implement robust corrective and preventative action (CAPA) strategies in TrackWise Quality Event Tracking System (ETS) using excellent analytical, cross-functional team work and advanced communication skills. Show less

• 

  Terumo Medical Corporation

  Jun 2019 - Mar 2021

  Senior Sterility Assurance Specialist / Engineer

  • Directing the overhaul of in-house Gamma Radiation sterilization process to ensure regulatory compliance and quality control per ISO 11137-1, -2. And -3.• Leading the implementation of new alanine dosimetry system including management of in-house training, IQ/OQ validation, PQ activities and integrating a new robust dosimetry system process into internal Gamma Radiation sterilization process per ASTM E61 Radiation committee standards and guidance. • Managing revisions and updates for all Gamma sterilization processes including authoring new/current standard operating procedures and forms• Developing an annual review program for Gamma Radiation Sterilization to ensure regulatory compliance and maintain quality control per ISO 13485• Leading and supporting cycle development for Ethylene Oxide sterilization of new and current products including full &/or reduced validation activities • Developing project plans using Microsoft Project, communicating effectively with internal cross-functional teams (i.e. quality, supplier quality, regulatory, NPD, production, distribution) and presenting updates and proposals to upper management and key stakeholders • Coordinating and communicating with external vendors (including but not limited to contract sterilizers and contract laboratories) for routine processing, nonconformance investigations, requalification activities and requirements, and validations• Leading and/or supporting supplier audits as sterilization Subject Matter Expert (SME) for both new and currently approved vendors. • Subject Matter Expert (SME) for the initiation, investigation, and resolution of all sterilization-related nonconformances Show less

• 

  Corning LifeScience

  Mar 2021 - Jan 2024

  • Developed and proposed organizational strategy to executive leadership to support growing Sterilization capacity. • Generated and assembled a new Sterilization Engineering team of 15+ employees including engineers, process & maintenance technicians in less than 2 years.• Lead cross-functional teams as Sterilization SME including executive leadership, operations, quality, regulatory, & engineering • Collaborated across global project teams to initiate, support, and manage strategic initiatives and drove key sterilization projects to enhance CLS capabilities and capacity.• Developed core competency strategy & roadmap for global sterilization: E-Beam, Gamma, & X-Ray Radiation; Ethylene Oxide• Developed/executed technical development, validation, routine sterilization, and re-qualification activities for CLS products.• Managed and supported installation, qualification, and Business Process Scale-up (BPS) of new, fully automated E-Beam and X-Ray Radiation Sterilization Systems (TT300 Dual-Beam Rhodotron)• Program manager for global E-Beam product qualification strategy; drove dose mapping execution of over 4000 product SKUs.• Lead new GEX B3 Radiochromic film dosimetry system installation, qualification, calibration, and training for E-Beam.• Directed optimization of in-house Gamma sterilization and dosimetry system processes to ensure long-term sustainability, including installation, qualification, and calibration for new GEX B3 Radiochromic film dosimetry system to harmonize across modalities. • Oversaw major change controls to update procedures, work instructions, and forms per ISO 11137-1, -2, -3, -4; ISO/ASTM 51261.• Presented updates to all levels of leadership including executive, division, and multiple plants/locations. Show less • Sterilization Subject Matter Expert within Global Division Engineering at Corning Life Sciences • Lead and supported company-wide sterilization initiatives including installation and qualification of a brand-new E-Beam and X-Ray radiation sterilization system and associated fully automated conveyance and material handling systems. • Lead engineering support and troubleshooting of existing Gamma Radiation Sterilization system.• Began building out sterilization engineering team from the ground up in 2021, and continued to drive evaluation of resource needs and allocation within the Engineering team as well as cross-functionally (including Quality and Operations) Show less

  • Sterilization Engineering Manager

    Mar 2021 - Jan 2024

  • Sterilization Technology Leader

    Mar 2021 - Aug 2021
• 

  SomaGroup LLC Sterilization Consulting

  Mar 2024 - now

  President / Owner

  • President / Owner of global sterilization consulting services company specializing in Sterilization and Sterility Assurance, including all Gas and Radiation Sterilizations Modalities; Medical Devices & Laboratory Equipment, Pharmaceuticals, and Combination Devices - Product Development / Design; Microbiological Methods / Validation; Biocompatibility; Packaging Development / Validation. Experience and Qualifications include: • Radiation Sterilization Equipment & Processes: Electron Beam (E-Beam); Gamma; X-Ray • Gas Sterilization Equipment & Processes: Ethylene Oxide (EtO), from bench top chambers to full size chambers; Nitrogen Dioxide (NO2); Steam (Autoclave); Dry Heat; VHP • Sterilization and Sterility Assurance Program / Processes - Strategy Development, Resource Planning & Recruiting / Management / Development; Project Management; Capital Budget Management / Planning; Full Sterilization Equipment & Associated Systems Validation (IQ/OQ/PQ and Production Business Process Scale-Up); Dosimetry Systems Installation, Qualification, Calibration and Integration; Product and Process Development; Product and Process Validation (Feasibility through IQ/OQ/PQ and Production Business Process Scale-Up), and more. • Available for “hourly” or one-time requests, short term projects (3-12 months), longer term projects (over 1 year with no limit) especially for high complexity projects, program management, remediation efforts, and more. • Welcome requests for collaboration; love opportunities to work together towards the most robust and sustainable solutions Show less