Process Validation Engineer - Agilent Technologies, Frederick, CO

CIP Cycle Development Skid Lead – Agilent Technologies, Frederick, CO- Lead validation engineer for clean in place (CIP) cycle development on a new oligonucleotide API facility, spearheading development and optimization of 48 CIP Recipes over 12 different circuits on a new CIP Skid.Validation Engineer – Agilent Technologies, Frederick, CO- Authored and executed commissioning, qualification, and validation deliverables: Design Qualifications, Installation and Operational Verification/Qualification protocols for new synthetic oligonucleotide manufacturing equipment including waste services, utilities, production equipment, and process vessels.- Supervised construction mechanical completion (MC) walks to ensure accuracy in construction.- Reviewed equipment turnover packages (TOP) and construction documentation including isometric drawings, RFIs, and vendor commissioning documents for accuracy

Gardasil Expansion Project• Technical Operations engineer supporting the validation of new Gardasil® and Gardasil 9® vaccine purification train for the HPV Expansion Project in Elkton, VA.• Authored, revised, and reviewed SOPs, strategy documents, sampling documents, process performance qualification protocols and final reports, utilities performance qualification protocols and final reports, process simulation final reports, cleaning development, cleaning verification, and cleaning validation protocols while ensuring safety and compliance to quality and cGMP systems.• Led key projects such as decommissioning/repurposing effort of bulk tank for use in new purification train, performance qualification of 10 cold rooms, and authored testing plan for shakedown and stability batches.• Led engineering shakedown sampling effort by authoring sampling and testing plan, collaborated with seven analytical labs within both Merck and CROs, ensuring all samples were taken, shipped, and passed acceptance criteria during shakedown and stability batches, and acting as site liaison to the Global Vaccine Operations group. • Led root cause analysis and investigation then ensured corrective actions of poor cold room performance during performance qualification and rouge remediation of buffer preparation, buffer hold, and purification equipment.• Supervised, mentored, and delegated work to junior contractors and trained technical operations and operations engineers in skills such as visual inspection, document control, authoring documents.

• Primary analyst performing therapeutic antibody upstream and in-process characterization of n- glycans utilizing Hydrophilic Interaction Chromatography (HILIC-UPLC) both manually and using Hamilton STARplus liquid handler systems.• Analyzed chromatograms and published data from HILIC and SEC experiments into a validated database for consumption by process development groups using Empower 3 chromatography software.•Performed and analyzed Host Cell Protein ELISAs for in-process intermediates and downstream samples.• Frequently cleaned, maintained, and performed troubleshooting for Waters UPLC and Agilent HPLC instruments running high salt buffers.• Monitored and analyzed chromatograms for SEC system controls using Empower 3.

Designed a Fischer-Tropsch reaction process to convert natural gas to diesel. Developed a process that converts natural gas to gasoline via a methanol intermediate. Created a process that physically converts natural gas to liquid natural gas. Compared costs and efficiencies of both processes.

I research bio-materials for controlled release of therapeutic drugs and conduct protein release studies of antibodies and hydrogels. I have performed microsphere hydrogel experiments using multiple processes to find the best method of production within the set specifications of size, shape, etc. I am proficient at Image J and imaging the hydrogels and microspheres. I specialize in cell culture within the Krebs Lab, being detailed-oriented and making sure the chemicals stay sterile.

•Researched the different available processes of ultra-high temperature pasteurization of dairy products.•Researched operation costs and overhead costs of the process.•Researched the socio-economic impacts of ultra-high temperature pasteurization.•Determined the optimal equipment and procedure for ultra-high temperature pasteurization.

Design and model a residence hall for international studentsResearch the costs and materials to build the residence hallWork as a team to complete the projectCreate a prototype of the residence hallSurvey international students

• Screened epigenetic drugs to determine a target epigenetic drug for use in pediatric ependymoma tumors.• Researched SIRT1 and SIRT2 epigenetic factors and their role in ependymoma cell proliferation and growth.• Performed in vitro experiments to test SIRT2 target epigenetic drug and its ability to limit ependymoma cell proliferation and growth. • Ran MTS/LDH assays, performed western blots, tissue cultured, analyzed DNA/RNA, performed confocal and IncuCyte imaging.• Presented research to fellow interns, mentors, and principal investigators.• Shadowed Dr. Foreman in the Neuro-Oncology Clinic at Children’s Hospital Colorado

•Shadowed the catheterization lab and nuclear medicine imaging.•Volunteered 90 hours in the emergency room, mom/baby floor, and breast care center.

I tutor eighth grade students on algebraic concepts by helping with homework assignments, retakes, and study skills to ensure students fully understand the material.