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Manufacturing Engineer

San Antonio, TX
November 21, 2018

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Cory Davis

San Antonio TX ***** 210-***-****

Solutions-Driven Manufacturing Engineer

Process development and scale-up to improve Quality and Yield

Accomplished in pharmaceutical R&D manufacture, including extrusions, process development, and pilot unit productions. Expertise includes cGMP processing, scale-up, maintenance and set-up of equipment, resolving process and equipment issues. Experience assisting and leading pharmaceutical production batches under cGMP regulations.

Provided management / supervisory services and technical / operational support as required. Broad skill set includes client communication, troubleshooting, writing proposals, requisitioning materials, preventative maintenance, repair, and careful documentation. Quality system trained and detail-oriented team member with strengths and skills in:

Pilot Unit Operations Master Batch Record Development and Usage Equipment & Process Troubleshooting



Research Engineer, Pharmaceutical & Bioengineering Department 2016 - 2018

Applied cGMP and cGLP principles to manufacture kilo scale (up to 200 liter) drug substances in Pilot Unit for use in animal and human studies. Performed process development on small gram scale, scaled-up to kilo scale, and developed and completed detailed documentation. Submitted cost estimates, procured raw materials, performed equipment IQ/OQ/PQ, equipment cleaning and set-up, and calibration.

*Secured larger scale, more profitable work by successful scale-up. Led and supported cGMP / cGLP productions through operations, quality, and purchasing which achieved target compounds at quality and quantity for client.

*Performed cGMP and engineering extrusions, including controlled substances, to produce various medical implants for research including human trails; included equipment cleaning, assembly, set-up, and packaging.

*Wrote and reviewed master batch records, block flow and process flow diagrams, and executed batch records for cGMP productions, ensuring compliance to federal code, quality program, and technology capture.

Quality control of nasal spray device: measured parts and spray tested to verify specifications and functionality.


Research Engineer, Chemical Engineering Department 2006 - 2016

Supported a large gas-to-liquids (GTL) research project for several years in a variety of roles: operator, maintenance & repair, data analysis, engineering support, and supervision of small pilot units. Became Coordinator of SwRI Services (CSS) for 20+ people in a 3-story, Process Demonstration Unit (PDU). Contributed proposals with coworkers and individually and helped to win several other research projects. Managed and planned client visits along with proprietary information and technical information on several hydrotreating projects as project manager.

*Served as project manager and client liaison on several hydrotreating projects which were successful in upgrading nontraditional crude oil sources to fuels.

*Supervised small GTL Pilot Unit, successfully capturing data and proving process concepts for development of the next phase of research.

*Leveraged and coordinated a variety of SwRI capabilities and resources for the client as CSS for the PDU to support operations in addition to evaluating personnel, requisitioning materials, and reporting to support project.

*Reviewed client contract terms, compared raw material pricing, and managed purchase orders for project success.


Laser Weld Maintenance/Production Engineer, 2006 - 2006

*Learned preventative maintenance on laser welder and ancillary equipment to support plant start-up.

*Assistant Supervisor of Kanban (equipment installation) system to pass city permitting process.


Quality Auditor (Contract) 2005 - 2006

Consulted with a small, contract petroleum laboratory to prepare for government audit.

*Audited laboratory and personnel for adherence to ASTM testing procedures. Findings and feedback prepared company to pass the audit, retain primary customer and stay in business.


Chemist, Quality Assurance / Raw Materials (RM) 2003 - 2005

Tested and approved samples from incoming lots of raw materials (RM) daily to keep up with 24/7 production. Planned and coordinated annual testing of RMs. Trained and supervised personnel in RM analysis and procedure. Created and modified laboratory SOPs, calibrated laboratory equipment and performed IQ/OQ/PQ and preventative maintenance, managed Failure Reports / Corrective Actions, assembled and filed daily reports of RM lot approvals.

*Resurrected and managed annual testing program for Raw Materials, increasing compliance and audit readiness.

*Maintained reference spectra for positive identification of RMs as System Manager of Raw Material IR Identification program (RMIRID), supporting compliance in positively identifying confirmation of ingredients.

*Implemented and validated SAP Quality Module, enabling the plant to become 21 CFR Part 11 compliant.

*Monitored stripe quality, supporting new initiative to quantify and improve product stripe quality.

*Collected and analyzed statistical data and identified trends for Quarterly and Annual Product Reviews which allowed plant to recognize and address potential quality issues.


Quality Engineer, QA Department 2002 - 2003

Assisted Sr. Engineer in resolving product quality issue with primary package. Collected and analyzed data from attempts to resolve issue. Evaluated new packaging materials on finishing lines during Experimental Manufacturing Orders. Compiled quality data and analytical charts for Annual Product Review of toothpaste formulas.

*Resolved tearing of internal divider of primary package for product, preventing quality and image issues from hurting sales by preventing package contents from reacting inside package on the shelf.


Bachelor of Science (BS), Chemical Engineering, Texas A&M University, College Station, TX


Board Member of 501(c)3 nonprofit, Jaxon's F.R.O.G. Foundation- spreading smiles to children with cancer

Sponsorship of hospital playrooms. Organize, and coordinate escape to fun events to help families create memories outside of the hospital environment. Design, purchase and assemble welcome bags for hospital and hospice patients.

Choose investments in childhood cancer research.

Board Member of Churchill Estates HOA

Training / Skills

cGMP, cGLP, ISO 9001, Productions involving Controlled Substances, NMR Infrared Analysis Spectral and Interpretation, AutoCAD, MS Excel / Word / PowerPoint / Access, Shopfloor, Minitab-Statistical software,

SNUM, SAP, Ultrasonic and Resistance Welding, CPR / First Aid, Forklift Operation, Arc Welding,

HAZOP What-If process safety reviews, 40hr HAZWOPER training

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