EDWIN ABREW

• National Field Installer of Cellular Tank Monitors, based out of Naples, Florida.
• Installed mobile cellular gauges to monitor fuel levels on residential and commercial fuel tanks.
• Executed installations of residential propane fuel tanks for major propane gas companies nationwide.
• Conducted installations of commercial fuels and lubes tanks for leading commercial fuels and lubes retailers.
• I travel throughout the United States on assignments for different fuel company projects..
• I am trained in the maintenance of Bio-diesel tanks for companies that collect spent cooking oil for repurposing.

• I performed service duties for residential pest control and conducted home inspections.
• Developed tailored pest control solutions to meet diverse customer needs.
• Built strong client relationships, enhancing customer retention and satisfaction.
• Analyzed market trends to identify new sales opportunities and drive growth.

• Executed roles as Scientific Equipment CSV Computer Systems Validation Contractor & Regulatory Consultant for Janssen and EMD Serono, ensuring compliance with regulatory standards.
• I established SunkissedEnergy.ORG - Solar Energy Consulting and collaborated with multiple roofing companies.
• Founded Gator Alley Services Transportation, contracting with UBER/LYFT and SpeedPack Express MIA to facilitate urgent delivery of Aircraft On Ground parts to area airports.
• Established SunkissedEnergy.ORG - Solar Energy Consulting, collaborating with roofing companies to promote sustainable energy solutions.

• Taught science classes on a per diem basis at Gateway Charter High School and Middle School. substitute teacher for Gateway Charter High School and Middle School.
• Developed engaging lesson plans to facilitate student understanding of scientific concepts.
• Adapted instructional materials to meet diverse learning needs and enhance classroom participation.
• Implemented classroom management strategies to maintain a conducive learning environment.

• 4 Month APAC & LATAM Audit-Cornerstone Consultant
• I assisted the Project Manager of the system owner during audits and confirmed all deliverables were completed on time with no significant audit findings.
• Managed deliverables list for upcoming audits, coordinating with stakeholders to meet deadlines.
• I ensured readiness of all deliverables in preparation for the CSV audits of internal computerized systems used by cGXP providers.
• Ensured readiness of deliverables for CSV audits of internal computerized systems utilized by cGXP providers.

• I provided project management and technical support for monitoring existing lab equipment and computerized systems of Pharmaceutical Analytical Quality Labs under cGMPs, CFR Part 11, Annex 11, Analytical Instrumentation Qualification (AIQ) SOP, data integrity best practices and current regulatory guidelines related to instrument calibration and computer systems validation.
• I managed project interactions and dependencies; provided project reporting and governance, and issue and risk escalation management and drove initiatives from requirements determination to project closure.
• Collaborated with IT to troubleshoot instruments and applications, oversee maintenance and retirement, and facilitate change management aligned with global and local procedural harmonization.
• I authored and reviewed validation documents, Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification protocols of lab instrumentation and data management applications.
• Managed project interactions and dependencies, provided project reporting and governance, escalated issues and risks, and led initiatives from requirements determination to project closure.
• I conducted research and incorporated industry best practices.
• I track and report high-level project status and identify and help projects in troubleshooting delays.
• I conducted project post-mortems and created recommendations reports to identify successful and unsuccessful project elements.
• I ensured compliance with all work instructions and standard operating procedures relevant to laboratory instruments and computer systems and submitted updates when needed.
• I created and approved WI, SOPs and forms that supported laboratory instruments and data management systems.
• I supported internal and external audits of Laboratory Instruments and associated Computerized systems.
• I conducted proper research and incorporated industry best practices as appropriate.

• Completed various courses to enhance skills and knowledge. Managed position transition during Pandemic lockdowns starting March 2020
• Completed training in troubleshooting and repair for Models 8860 and 8890 under GC Support SPIFPM
• Completed training on OpenLab CDS Workstation Basics.

• Advanced to a role in the Fuels Processing Optimization Group as a Research Associate
• Collected and processed catalysts for multi-year refinery project studies, including pre- and post-sampling for analytical testing as required.
• Technical and processing support for Engineers and Project Leads of Renewable Energy projects.
• Maintained and updated catalyst inventory to ensure adequate quantity for FPO and pilot plant reactor loading requirements.
• Provided technical and processing support to engineers and project leads for renewable energy projects.

• Operated four 'Fuels' unit reactors handling independent studies led by individual PIs.
• Maintained hydrocarbon fuel processing units by checking performance and production values, adjusting and monitoring pressure, temperature, and product quality.
• Executed troubleshooting, sampling, analytical testing, and routine maintenance to uphold operational integrity and product quality.
• Processed hydrocarbon and bio-fuel blends, including their products and by-products, using established techniques.
• I use Honeywell TDC 3000 and LabVIEW systems to control feed gases such as hydrogen and nitrogen.
• I am trained and certified for the use of respirators for loading and unloading of catalysts when assembling reactors.

• Quality Assurance Unit (QAU) Business Analyst - Instrumentation Validation Specialist
• I manage, maintain and regularly audit the Labguard environmental monitoring system by Biomerieux consisting of close to 100 sensor probes, constantly monitoring ambient and equipment data for all four lab sites/buildings and over 40 chambers consisting of Incubators (CO2), Refrigerators, Freezers and -80 sub-zero cryogenic freezers.
• I coordinated the calibration program for all laboratory equipment in 'Raw Materials/Wet Chemistry', 'Microbiology', Container Closure Integrity Testing "CCIT", and 'Medical Device Testing and Development' Labs and schedule service providers. I have updated and prioritized schedules and service types to maximize effectiveness.
• I independently write and review protocols for equipment, applications and service maintenance.
• I critically evaluate vendor protocols, revise and approve them under the MOC (Method of Change) process.
• I update all instrument service labels following service, maintenance, validation and repair.
• Maintained and developed site computerized equipment data management system E-Maintenance; introduced BMRAM to enhance management of calibrations and preventative maintenance programs.
• Issued monthly service reports to lab management, ensuring timely completion of scheduled maintenance.
• I assured adherence to equipment SOPs and other regulatory requirements and wrote and revised SOPs.
• I provided troubleshooting support for minor instrumentation issues and assisted vendors in completing validation services.
• I initiated and completed Quality Assurance procedures such as CAPA, OOT, OOS, and Deviations related to instrumentation.
• I initiate and/or complete Quality Assurance procedures such as CAPA, OOT, OOS and Deviations as they apply to instrumentation and as they progress from a traditional handwritten system to the STRATAS paperless system.

• Acted as a liaison among corporate headquarters, customer service, and the client base by providing product information, including pricing and promotional programs, while gathering market data on competitive products.
• Knowledge of the entire product portfolio consisting of lab equipment, plastic consumables, bio-reagents, buffers, ECL film and re-agents as well as niche research product lines for Drosophila, c. elegans and other Model organism research.
• Scheduled cyclical recurring visits to all clients within territory, including private companies, research labs, and academic institutions in NYC and the rest of New York State.
• Responsible for the scheduling of cyclical recurring visits to all clients within territory comprising private companies and research labs as well as academic institutions and organizations in NYC, and the rest of New York State.
• Grew territory exposure of products by reaching out to new labs and building relationships with the existing customer base.
• Transformed product sample transport method from crude cart to professional multi-compartment case, enhancing customer access in formal settings.

• Product Prototype Development of the 'Atellica Solutions' Immunoassay and Clinical Chemistry Analyzer
• Tested and troubleshot engineering tasks, emphasizing systems engineering principles to ensure reliability.
• Assembled, retrofitted, and developed prototypes, conducting testing to validate design functionality.
• Assembling, retrofitting, and prototype development and testing.
• Supported engineering studies by gathering data and collaborating with team members., processes, designs, inspections and quality audits.
• Gathered, recorded, and maintained engineering-specific information.

• Executed field service tasks including maintenance, repairs, and installations of laboratory equipment.
• Trained staff on troubleshooting and repair of laboratory instruments, enhancing team capabilities.
• Trained in troubleshooting and repair of industry related laboratory instruments.
• Achieved revenue targets while remaining under budget.
• Complied with ISO standards and maintenance of proper parts inventory.
• Interfaced with the Sales team to meet customer requirements.
• Assisted and cooperated with fellow Service Support Reps to ensure service standards and data and integrity.
• Resolved customer complaints and invoicing issues, improving customer satisfaction and operational efficiency.

• Conducted research in product development - Product Development Technician
• Executed laboratory testing for product development and verification, contributing to effective production scale-up.
• Collaborated on development of medical devices from human and animal tissue, ensuring compliance with regulatory standards.
• Monitored process and equipment performance while implementing development initiatives using laboratory and processing equipment across lab, pilot, and plant production scale-up environments.
• Participated in Human Adipose Tissue development process study, which required an extension of a three-month contract.

• Implemented safety protocols to enhance workplace safety standards.
• Executed tasks autonomously to achieve project objectives.
• Managed product complaints using the electronic system CHATS.
• Delivered timely responses to customers, ensuring efficient closure of product complaints.
• Differentiated between product inquiry and product complaint.
• Utilized statistical tools to provide Technical and Sales Marketing groups with appropriate information on field product quality.
• Assisted facilities by ensuring compliance during audits.
• Aided Project Managers by coordinating project activities.
• Supported safety and environmental initiatives.
• Analyzed trends and factors for Operations and Technical staff management to facilitate effective resolutions.
• Managed product complaints from inception to closure, including follow-up on corrective actions.

• Clinical & Commercial Bio-Pharmaceutical Manufacturing
• Nominated for 'Train the Trainer' program during the first year and certified as a peer trainer to teach the next generation of process associates to staff additional immune-manufacturing sites in Seal Beach, CA, and Union, GA.
• Developed tracking matrix to monitor operator cell recovery, promoting product quality throughout the manufacturing process.
• Trained colleagues on production methods to ensure compliance with SOP changes. colleagues on production methods to ensure compliance with SOP changes.
• Participated in both validation events that led to FDA approval for full production capacity.
• Served as a department liaison to the IT department and assisted with the installation and procurement of equipment in controlled areas including clean rooms.
• Conducted facility-wide safety compliance inspections and reported back to the EHS manager.
• Proposed CAPA to enhance sterility sampling during production, reducing unnecessary investigatory suspensions and maintaining productivity.

• Provided technical service support and training of lab personnel.
• Delivered technical service support and training to lab personnel, enhancing their operational capabilities.
• Evaluated product development opportunities and applied innovative ergonomic equipment solutions to meet user needs.
• Identified areas for product development and applications of innovative ergonomic equipment.
• Collaborated with technicians, physicians, principal investigators, and directors to launch ergonomic product lines and provide on and off-site maintenance and calibration services.

• Promoted after acquisition by Celgene, leading to expanded responsibilities in research and development.
• Cross duties in commercial development and production of Ambiodry were undertaken.
• Completed training program of tissue decellularization and desiccation process.
• Proposed comparison study using single blood pool technique to evaluate efficacy of Hetastarch gradient cell separation versus Ficoll-Paque overlay for cell isolation.

• Acquired proficiency in proprietary processing of blood perfusate from placenta through blood vessel cannulation methods, enhancing collection of umbilical cord blood and optimizing stem cell separation and cryogenic storage techniques.
• Contributed to development of procedures for the isolation and cryogenic storage of CD34 Stem Cells from raw blood perfusate.
• Collected and processed cell samples for FLOW, FISH, Cell-dyn and other processes.
• Collected and processed cell samples for flow cytometry, fluorescence in situ hybridization, and Cell-Dyn, supporting various analytical processes.
• Selected to perform manual viability study. Manual Viability study for comparison with automated methods.
• Developed and implemented procedures and SOPs for maintenance of lab equipment, ensuring operational reliability and compliance.

• Biopharma Haz-Mat Logistics Customer Support
• Weekend Customer Service Support Self-supervised
• Delivered packages across NYC, ensuring timely and safe deliveries while maintaining customer satisfaction.
• Transported employees across tri-state area, coordinating schedules to meet operational needs.
• Provided customer service support during weekends at retail location. Self-supervised

• SCRUM Study - AGILE & SCRUM Master Certified
• Harvardx CS109x - Introduction to Data Science with Python
• Harvardx CS50x - CS50 'Introduction to Computer Science'

Certificate of Secondary Education in Science