Project Management Process Engineer

Yara Mohamad 513-***-**** ************@*****.*** *877 Pepperridge Ct, Maineville OH 45039

Summary

Adaptable Engineer seeking new opportunities to leverage background in process engineering, GMP manufacturing, MSAT and problem solving to contribute to a dynamic team and drive innovative solutions while enhancing company performance. Core Strengths

Process Optimization Project Management Client Communication Team Management Design/Safety Engineering Education & Training

BSE, Chemical & Biomolecular Engineering, The Ohio State University Modeling & Analysis: ChemCAD, SuperPro, Solidwords, JMP Software & Tools: Delta V, UNICORN, TrackWise, SAP, SFLMS, Documentum, DevOPS, Matlab, Office Suite, BMRAM Manufacturing Skills: Cleanroom Readiness, P&ID Review, Fill Finish Isolator Operation and Troubleshooting, GMP, GDP, Upstream/Downstream bioprocessing, Equipment, PPI, SOPs/WI’s, PBRs Unit Operation Experience: Autoclave, WFI Systems, Bioreactor, AKTA, VERDOT, SUM, TFF, LLE, Distillation, RO, Barrier Films, Plate Heat Exchanger, Gas-Solid Liquid Fluidization Lab Skills: Molecular Cloning, Cell Culture Maintenance, Transfection of Host Cells, Organized Reports, DoE SAChE Certified in Industrial/Facility Process Safety (ELA952, ELA967, ELA 973, ELA974, ELA984) Volunteer History: AIChE Class Representative (American Institute of Chemical Engineers), HOBY, GES, R-LEAD Professional Experience

Process Engineer / Scientist MSAT Thermo Fisher Scientific Cambridge MA 02142 Feb 2022 – Jan 2024

Compiled data for clinical pre-commercial client to evaluate yield losses across product streams.

Designed and performed experiments in the investigation of OOS yield results for pre-commercial product including PD work in laboratory setting for the re-launch campaign to get first of its kind biological therapeutic to commercial market.

Contributed to substantial cost savings through review of technical documentation and re-evaluation of minimum and maximum working volumes of high raw cost materials.

Optimized operations workflow to reduce unit operations waiting time and increase yield of time sensitive products.

Designed experiments and led deviation investigations of OOS product results using RCA tools.

Conducted technical trainings and revised documentation to mitigate in-process risks and streamline operations.

Supported client and FDA audits and analyzed data for client communication, technical reports, process qualification summaries and root cause investigations.

Collaborated with global team to transfer ideas and streamline operational standards across sites leading to cost savings and quality products.

Collaborated with product team in new product/patent creation while driving transition to company owned products.

Served point of contact for Manufacturing, MST, Engineering, Automation, QC, and QA for all questions related to operations, personnel, documentation, materials, planning, PPI, PPQ readiness, and investigations.

Assisted in CPV validation technical data compilation and report closures.

Ensured facilities and equipment maintained cGMP compliance while maintaining a safe work environment.

Supported and coordinated vendor on-site maintenance of equipment to extend equipment lifecycle.

Tracked and communicated site change controls in the introduction of new equipment and supported equipment replacement evaluations.

Conduct equipment investigation to troubleshoot equipment malfunction and process inconsistencies.

Conducted testing of equipment software to evaluate if software met necessary qualifications.

Supported PPI initiatives in decreasing human error through reduction of man-power related activities. Formulation Manufacturing Technician II Thermo Fisher Scientific Cambridge MA 02142 Jul 2021 – Feb 2022

Proactively identified and contributed to substantial cost savings (>$16 million) in supply chain through inventory management initiatives.

Assisted in new member onboarding training and coaching in upstream and downstream operators and held Qualified Trainer (QT) status on a wide variety of operations/equipment/software.

Documented process in real time in production batch records with 0% deviations due to GDP or human error while identifying inconsistencies in workflow and driving improvements to ensure maximum efficiency of available resources, personnel, and equipment.

Applied cGMP regulatory and project management knowledge towards conducting investigations, root cause analysis, revising documentation and driving continuous improvement initiatives.

Served as the operations point of contact for Manufacturing, MST, Engineering, Automation, QC, and QA by providing consistent reports regarding manufacturing efficacy, deviations, and overall team effectiveness.

Operated manufacturing systems including DeltaV, LIMS, Trackwise and material tracking and management through SAP.

Troubleshooted process equipment and deviations under high-pressure and time constrained conditions.

Lead daily tier huddles in operations scheduling and execution.

Performed equipment preventative maintenance on manufacturing equipment used for the production of biologics.

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