Head of Validation across pharmaceutical manufacturing of Animal Health products in Athens, GAManage validation program ensuring alignment with all regulatory and corporate requirements (USDA, GxP, ISPE, etc)Author, implement and maintain the site validation master plans, SOPs, and required documentsPerform cross functional support in the selection, review, acquisition, and upgrade of production equipment and ensuring execution of all IO/OQ/PQ activities including CSV&CProvide… Show more Head of Validation across pharmaceutical manufacturing of Animal Health products in Athens, GAManage validation program ensuring alignment with all regulatory and corporate requirements (USDA, GxP, ISPE, etc)Author, implement and maintain the site validation master plans, SOPs, and required documentsPerform cross functional support in the selection, review, acquisition, and upgrade of production equipment and ensuring execution of all IO/OQ/PQ activities including CSV&CProvide validation support in deviation investigations and change controlEnd to end responsibility for cleaning, process validation, utility, process systems and process support systems qualification, test execution and summary reports Show less

Head of GSAH (Global Supply - Animal Health) environmental sustainability programEstablish GSAH environmental sustainability targets & governanceMonitor & Drive GSAH network site environmental sustainability performance across energy, emissions, water and waste categoriesDevelop individualized site sustainability strategies to achieve Carbon Neutrality (in company operations) according to company goalsCapital Project Sustainability Integration SM. Develop tools and target… Show more Head of GSAH (Global Supply - Animal Health) environmental sustainability programEstablish GSAH environmental sustainability targets & governanceMonitor & Drive GSAH network site environmental sustainability performance across energy, emissions, water and waste categoriesDevelop individualized site sustainability strategies to achieve Carbon Neutrality (in company operations) according to company goalsCapital Project Sustainability Integration SM. Develop tools and target setting method for single and group projects in Animal HealthLead and Support GSAH environmental sustainability projects and initiatives for decarbonization, renewable energy, circular economy and water stewardshipDevelop Animal Health Eco-Design strategies for Global Supply with Global Innovation (Research & Development)Foster GSAH network collaboration and best practice sharing for environmental sustainability Show less

Provide project management services on capital projects including feasibility studies, preparation and presentation of Investment Applications to secure funding, design development, construct document preparation, A/E, CM and General Contractor evaluation and selection, bids solicitation and review, contract administration, overall construction management, commissioning, validation and startup.Develop, review and establish Basis of Design criteria with user department and operating… Show more Provide project management services on capital projects including feasibility studies, preparation and presentation of Investment Applications to secure funding, design development, construct document preparation, A/E, CM and General Contractor evaluation and selection, bids solicitation and review, contract administration, overall construction management, commissioning, validation and startup.Develop, review and establish Basis of Design criteria with user department and operating management.Provide coordination of outside design firms during preliminary and detailed project planning activities. Perform value engineering analysis and comparisons for conformance to Basis of Design criteria and industry accepted engineering standards.Develop project budgets and schedules, review engineering drawings. Provide technical support to operating units, as requested.Inspect construction in-progress, track costs for budget conformance, approve progress payment and change orders, monitor schedule and contract document conformance. Provide project report on a monthly and quarterly basis documenting status of aforementioned activities.Define scope and implement project feasibility studies.Ensure proper closeout of project including all project documentation, financial aspects, lien releases, and facility engineering interface.As assigned, manage/direct long range master planning for all or part of the site and/or facilities.As assigned, manage or direct operational, administrative, maintenance or other related programs and tasks. An example of an operational program is responsibility for managing the insurance requirements and fire protection system.Oversee contractors. Show less

Area Engineer for a Pharmaceutical Development Plant, Research and Development, and Regulated Waste Storage Buildings (BS Chemical Engineering, MBA, Green Belt Certified)Facility and Process Maintenance Engineer:-Responsible for maintenance and systems reliability engineering in a GMP, GLP Pharmaceutical Development Plant including building HVAC, boilers and chillers, fire protection systems, process exhaust (fume hood/down flow booth), lab gas and piping systems, process chillers… Show more Area Engineer for a Pharmaceutical Development Plant, Research and Development, and Regulated Waste Storage Buildings (BS Chemical Engineering, MBA, Green Belt Certified)Facility and Process Maintenance Engineer:-Responsible for maintenance and systems reliability engineering in a GMP, GLP Pharmaceutical Development Plant including building HVAC, boilers and chillers, fire protection systems, process exhaust (fume hood/down flow booth), lab gas and piping systems, process chillers, vacuums and scrubbers-Develop and implement preventive maintenance procedures to ensure all facility and process equipment are maintained to minimize downtime -Implement six sigma, LEAN and green belt methodology on facilities systems to improve system efficiency, performance, reliability and energy conservation-Conduct troubleshooting (RCA, PFMEA) of building and process systems and issue CAPAs as needed-Implement life cycle costing and equipment recapitalization for antiquated systems-Responsible for internal and external contractor management -Budget planning, design and project execution of engineering upgrades to extend system life and satisfy user requirements-Interface with building management, Quality Assurance, Validation, Engineering Compliance, EH&S personnel and engineering firms -Ensure all equipment and building modifications meet GMP/GLP/GxP, FDA, and chemical safety requirements-Site SAP Data Manager for equipment and maintenance organization Capital Project Management: Small Capital Project Management (< $5 MM)Large Capital PM Support (>$5 MM)Draft and Execute Factory Acceptance Test (FAT), Site Acceptance Test (SAT)Subject Matter Expert:EHS&S Corporate "BeGreen" Sustainability SME EHS&S Corporate Fire Protection Procedure: Training, Project Incorporation Regional Network Support (Animal Health, Human Pharmaceuticals, Bio-pharmaceuticals)Diversity Inclusion and Engagement Business Resource Group Chair - GenerationBI Show less

ISEE (Infrastructure, EHS, Engineering): Chemical EngineerProcess Development Lab Facility and Project Engineer (March 2016-present):-Maintenance troubleshooting on processing, facility, utility equipment-Develop maintenance procedures wrt downtime minimization and equipment performance-Manage and execute internal and external work orders-Provide technical direction to contractors and suppliers wrt processing systems, GMP, safety and reliability-Process Engineering… Show more ISEE (Infrastructure, EHS, Engineering): Chemical EngineerProcess Development Lab Facility and Project Engineer (March 2016-present):-Maintenance troubleshooting on processing, facility, utility equipment-Develop maintenance procedures wrt downtime minimization and equipment performance-Manage and execute internal and external work orders-Provide technical direction to contractors and suppliers wrt processing systems, GMP, safety and reliability-Process Engineering Project Management Support -CAPA: Change management and preventive action implementation -GMP/GXP process and facility equipment design implementation-P&ID Field Verification and Change Control-Building Equipment Management and Maintenance-Contractor Management -Safety Analysis on Process EquipmentRegional EH&S: Corporate Fire Protection Procedure (CoFiPP) SME for Building and Project Risk Assessments. Regional Integration support and information exchange across U.S.Building and Project Risk Assessments for:-Animal Health Production -Chemical Pilot Plant -Office Renovation/Warehouse -Bio-pharmaceutical ProductionCapital Expenditure Analysis; Portfolio preparation for tracking spending with respect to budget.-Fremont Bio-pharmaceutical production site CapEx and Portfolio Analysis Jan. 2017-Long Term Forecasting (LTF) Budget Planning for ISEE and R&D Capital Projects -Accounting Change Analysis and CapEx/OpEx budget impact-BI Bio pharmaceutical Global CapEx Trending and Analysis 2011-2015LEAP/AAI Team Member: internal business communications and information cascadeBusiness Resource Groups:-Women's Leadership Initiative -NxGen: Next Generation -CABS: Disability Awareness and Inclusion Show less

6 Month Extended Business Trip for Engineering in Biberach, Germany3 Months: Biopharmaceuticals Engineering & Technology Department-Process Documentation Changes; Clinical Bio-pharmaceutical Production-Project Support: Bio-fermenters for laboratory use for process development-EHS: Equipment Documentation, Team-based Risk Assessment-CapEx: 5 year Bio E&T department CapEx analytics and analysis3 Months: ISEE (Infrastructure, Safety, Environment… Show more 6 Month Extended Business Trip for Engineering in Biberach, Germany3 Months: Biopharmaceuticals Engineering & Technology Department-Process Documentation Changes; Clinical Bio-pharmaceutical Production-Project Support: Bio-fermenters for laboratory use for process development-EHS: Equipment Documentation, Team-based Risk Assessment-CapEx: 5 year Bio E&T department CapEx analytics and analysis3 Months: ISEE (Infrastructure, Safety, Environment, Engineering)-Building and Process Automation: HVAC, Process Controls, IT Data Management-Plant Engineering: Clinical Supply, Clinical Process Development-Laboratory and Equipment Design: Laboratory and Pharmaceutical Robotics, Augmented Reality Concept DesignGlobal Engineering Network ConferenceBiopharmaceutical Engineering and Technology Compliance Workshop Show less

Proposed a design to increase throughput of wellhead gas in a preexisting gas plant. Simulated amine treatment, dehydration, and cryogenic separation with a turboexpander and demethanizer column using Aspen HYSYS.Designed and priced all equipment using GPSA and Seider engineering handbooks.Performed economic sensitivity on the price of the well head gas, NGL, and methane. Analyzed the risk/benefit for using electric vs. gas powered compressors. Presented a full report with… Show more Proposed a design to increase throughput of wellhead gas in a preexisting gas plant. Simulated amine treatment, dehydration, and cryogenic separation with a turboexpander and demethanizer column using Aspen HYSYS.Designed and priced all equipment using GPSA and Seider engineering handbooks.Performed economic sensitivity on the price of the well head gas, NGL, and methane. Analyzed the risk/benefit for using electric vs. gas powered compressors. Presented a full report with estimated pay back period, ROI, NPV and other recommendations. Show less