• Designing experiments and research plans to develop new and/or improve drug product processes for pharmaceutical formulations.• Being a subject matter expert on key unit operations including but not limited to spray drying, blending, dry granulation, tableting, and film coating. • Utilizing risk assessments to effectively communicate and plan future studies relative to drug product formulations and processes. • Understanding and designing experiments to challenge the effect of process parameters on quality attributes, including but not limited to design of experiments and one-factor-at-a time workplans. • Developing and implementing operational systems, protocols, procedures, and work instructions focused on process equipment and/or facility operations.• Assisting operations in batch record drafting, approval, execution and/or review when required with a focus on technical and operational leadership.• Collaborating with clients and suppliers on operational requirements to successfully manufacture clinical batches.

New Product Development Engineer• Provided technical input to medical device design by developing test methods and conducting experiments to understand characteristics and determine acceptable limits to meet necessary intended in-vivo conditions.• Applied technical fundamentals from material science and physiology to support experimentation, test method development, material selection, and device design to determine acceptable limits to meet requirements.• Assessed various regulatory standards include ISO standards, MDR requirements, cGMP guidance, and related in order to ensure compliance of test methods and design documentation.• Created technical documents and reports to summarize design work and decisions in order to present to stakeholders and business leadership in support of design readiness.Quality Engineer• Ensure product quality and release of acceptable product through technical non-conformance reports, CAPAs, and change control by performing root cause and statistical process analyses.• Complete engineering evaluations and reports of returned complaint devices to identify cause and failure associated with device, if applicable implemented process improvements to error proof failure modes.Process Engineer• Develop equipment and processes to meet user requirements and complete associated validations including installation, operational, and process qualification; spearheaded 3 equipment and 2 process validations.• Collaborate with manufacturing and maintenance teams to troubleshoot equipment in the event that machine issues arise, successfully corrected issues with 6+ different pieces of equipment.• Identify and complete continuous improvement projects by applying Lean Six Sigma technics to decrease downtime and increase yield alongside quality; collaborated on project to increase process yield by 2% saving approximately $1MM over 5 years.

• Conducted various industrial biotechnology projects from either commercial clients or researchers following strict biosafety level 1 protocols and procedures.• Operated fermenters ranging from 5 liters to 300 liters to produce both wild-type and recombinant microorganisms.• Monitored fermentation by pH, dissolved oxygen, turbidity, optical density, temperature, and pressure then corrected for any discrepancies from the designed process.• Utilized downstream processing techniques to purify desired product and then evaluated the purity and composition using HPLC and FPLC.• Collaborated with fellow researchers to design experiments, trouble shoot problems, and summarize findings to the customer.

Participated in a variety of training activities such as drilling, production, and subsea operations. Conducted simulated production operation which involved controlling many unit operations and following a strict procedure. Completed a water survival training which included participating in a simulated helicopter crash and escape.

• Analyzed new industry trends in the industrial adhesive field, focused specifically on food and beverage packaging.• Designed and completed multiple experiments utilizing Minitab and Excel while following strict safety protocol and procedures.• Prepared and presented a comprehensive presentation to management group and additional application engineers, including planning for both in person and call in attendees.

• Worked with wait staff to resolve customer needs; sanitized and cleaned all restaurant areas.