Summary
Overview
Work History
Education
Skills
Websites
Timeline
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Roya MOJTAHEDI

Pleasanton,CA

Summary

Leveraging process /manufacturing engineering experience in biotech as a staff manufacturing/validation Engineer. Recent expertise in process and equipment validation in Biotech Micro Array fab. Expertise in scaling up R&D projects through tech transfer for high volume manufacturing (HVM) and align them with ISO13485 manufacturing requirements.

Overview

19
19
years of professional experience

Work History

STAFF Microarrays Validation Engineer

Agilent Technologies
02.2016 - Current
  • Validation and Process engineer for Oligo Nucleotide’s synthesis including manufacturing, deprotection and cleaving processes
  • Validation of new processes, equipment and instruments in Micro-Array fab
  • Validation of new reagents (Phosphoramidites), solvents and other raw material for Oligonucleotide synthesis, deprotection and cleaving systems
  • Validation of equipment software
  • Extensive data analysis with JMP and Minitab for determining sample size for validation, statistical analysis of validation results including interaction between variables
  • Extensive use of Spotfire visual data analysis software for data analysis presentations and reports.
  • Responsible for all IQ, OQ and PQ validations related to Oligo manufacturing
  • Equipment: Vacuum systems, Centrifuge, UV-Vis (Agilent and Nanodrop), Rheosense, MicroViscometer, Wet benches
  • Closely working with QC development group for defining and optimizing QC Metrics for in Process and Final product
  • Supporting and owner of several fab equipment as a process engineer
  • Maintaining tools, defining PMs and troubleshooting with tool vendors for issues arising from those tools.
  • Mentored junior engineers in best practices for validation engineering methodologies improving team skillsets.
  • Established strong working relationships with vendors ensuring smooth communication during project deployment.
  • Conducted root cause analysis on deviations during validation activities, enabling timely resolution of technical issues.
  • Reduced operational risks associated with validated systems through periodic review assessments and targeted revalidations when necessary.
  • Generated validation plans for [Type] projects, setting specific temporal and budgetary goals for development and delivery.
  • Managed multiple validation projects simultaneously while adhering to strict deadlines and budget constraints.
  • Contributed to successful audits by providing detailed validation documentation and addressing any regulatory findings promptly.
  • Collaborated with cross-functional teams to resolve complex issues, resulting in reduced downtime and increased production output.
  • Improved validation processes by developing and implementing risk-based strategies for equipment, systems, and facilities.
  • Documented entire validation process, noting changes or alterations completed.
  • Produced and maintained technical documentation for project reference.
  • Demonstrated new product features and functionality to project stakeholders.
  • Proposed development and testing improvements to positively impact usability, function and performance.
  • Identified causes of equipment failures and made suggestions for issue resolution.
  • Developed and delivered training programs for operations personnel increasing understanding of validation procedures.
  • Assisted in creating a centralized repository for all validation documents streamlining access for future reference.
  • Analyzed pre-release software titles for compliance with User Requirement Specifications (URS), referring any deficits to appropriate personnel.
  • Ensured regulatory compliance with FDA guidelines by conducting thorough validations and maintaining accurate documentation.
  • Explained highly complex information in terms easily understood by non-technical personnel.
  • Streamlined the revalidation process by identifying opportunities for consolidation or elimination where appropriate.
  • Collaborated on Standard Operating Procedure (SOP) development, incorporating input from [Type] team to reduce liability and enhance successful deployments.
  • Utilized statistical tools such as Six Sigma methodologies contributing to data-driven decision making during validation processes.
  • Provided technical expertise during the design phase of new equipment installation projects increasing efficiency.
  • Participated in system design and commissioning phase, interfacing directly with clients to ascertain clear, concise milestones for integration into development timelines.
  • Optimized manufacturing efficiency through the development of robust process validation protocols and execution of performance qualifications.
  • Trained and assisted staff in validation techniques, methods and testing processes.
  • Supported new product introductions by validating equipment, processes, software, and cleaning procedures as required.
  • Implemented continuous improvement initiatives for validation processes, leading to enhanced product quality and cost savings.
  • Led risk assessment meetings, offering input on assessments such as system impact, component criticality, data integrity, and other factors.
  • Authored validation protocols for [Type] systems, verifying compliance with internal policies and external safety requirements such as [Area of Certification].
  • Worked with stakeholders and team members on quality assurance efforts for hardware components.
  • Collaborated with cross-functional teams for identification and resolution of validation issues.
  • Monitored and reported on test results and performance data to identify areas of opportunity for improvement.

Staff Process Engineer

Complete Genomics
03.2011 - 10.2015
  • New material qualification from suppliers like: GDSI (dicing company), cypress (wafer fab), Jazz (wafer fab), Fralock (PSA), Zeiss (Glass fabrication), Stack Plastics (molded PEEK frame)
  • New equipment qualification (Disco dicing, resist coater, fixtures, Asymtek adhesive dispense system, Amerimade Wet bench, Accretech Laser dicing)
  • Established control charts for process monitoring
  • Defining validation protocol and reports according to ISO13485
  • Prepared IOQs and PQ protocols for new equipment installation operational qualification and performance qualification
  • Managed and operated flow-cell manufacturing equipment including YES IST CVD systems, Accretech laser dicing, Amerimade Wetbench, Asymtek adhesive dispense
  • Performing root-cause analysis for trouble-shooting defects resulting from materials/processes
  • Improved processes for eliminating/minimizing defects and analyzing the correlation with sequencing yield.
  • Provided technical assistance to production team when issues arose.
  • Evaluated new technologies and equipment upgrades to enhance overall process capabilities, ensuring market competitiveness.
  • Coordinated with suppliers to resolve raw material issues affecting production schedules.
  • Optimized manufacturing processes by implementing continuous improvement initiatives and lean methodologies.
  • Participated in project reviews to enable ongoing status tracking and reporting.
  • Analyzed critical line data to make recommendations for improvement.
  • Reviewed processes, identifying areas requiring improvement.
  • Collaborated with cross-functional teams to improve product quality, resulting in increased customer satisfaction.
  • Managed third-party contractors, inspecting completed work and ongoing efforts to confirm quality and adherence to prescribed guidelines.
  • Implemented standardized work instructions, enhancing operator understanding of critical tasks and improving workflow consistency.
  • Identified bottlenecks in the production line through capacity analysis studies, increasing overall throughput rates as a result.
  • Reduced production downtime by conducting thorough root cause analyses and implementing corrective actions.
  • Conducted root cause analysis to identify, prioritize and eliminate process losses.
  • Coached newly hired employees and interns while observing progress and delegating tasks.
  • Championed and facilitated kaizen events to drive continuous improvement efforts throughout the organization, resulting in a culture of operational excellence.
  • Developed documentation, diagrams, and specifications to meet project requirements and regulatory standards.
  • Designed and executed experiments to identify process improvements, leading to reduced costs and increased efficiency.

Senior Process Engineer

JSRMicro
03.2007 - 03.2011
  • Polymer photoresist development engineer with focus on customer defects in polymer’s chemistry (Intel, IBM, Qimonda and smaller companies)
  • Developed processes and optimized photoresist formulation to reduce pattern defects
  • Planned and executed DOEs for defect reduction on 193 nm exposure technology
  • Leveraged following lab equipment in polymer development: Nikon exposure, Applied Sokudo Track and KLA Tencor defect analyzer, Hitachi and Applied material CD SEM tools, Thermawave/Optiprobe ellipsometer film thickness measurement tool (this includes manual operation and creating recipes for auto run) Managed technology transfer team for ramping up new photoresist formulation from lab scale to mid-scale (1-2 Gallon) in HVM facility (a transition stage between and lab made sample and HVM)
  • Executed qualified transition stage production equipment and processes on new resist formulas
  • Lead resolving customer related defects
  • Designed and conducted experiments to analyze impact of different resin mixtures with photo acid generator (PAG) and quenchers
  • Created database for customer defects with Microsoft Access
  • Performed extensive study on impact of Track pumps and filters on resist defects.

Process Development Engineer

Cypress Semiconductor
05.2005 - 03.2007
  • STI (Short-Trench Isolator) layer module owner
  • Developed and implemented One Step Etch with in-situ clean for STI to replace Two step Etch
  • This development not only improved defects but saved costs by eliminating one step
  • Performed screening experiments to identify process knobs for process optimization
  • Responsible for defect analysis at different layers in 60nm process of SRAM silicon fabrication by optimizing defect equipment based on absorption and reflection of UV light and visibility of defects with different bandwidths
  • Chemical microanalysis of defects with EDX (Energy dispersive X-ray) spectroscopy (determining elements that made defect) Leveraged DOE and data analysis with JMP software for modeling experiments and fractional factorial designs.
  • Collaborated with cross-functional teams to drive continuous improvement initiatives and achieve operational excellence.
  • Conducted training sessions for operators on proper handling procedures, reducing incidents of equipment damage or downtime.
  • Participated in design review meetings, offering insightful feedback on manufacturability concerns during early product development stages.

Education

Master of Science - Chemical Engineering

U.S.C
Los Angeles, CA

Bachelor of Science - Chemical Engineering

University of Tehran
Tehran

Skills

  • Interdisciplinary Engineering Experience in biotechnology, microarray fabrication, chip manufacturing Polymer photoresist production scaling design, and process control expertise Experience that includes leadership, key contributor positions I have success in working with interdisciplinary teams including R&D for development and test for deployment of a robust process in production Part of R&D designs review team to verify designs meet operational limits, DFM (design for manufacturability) Root cause analysis of defects/issues arising on a day to day basis Statistical analysis Correlation studies, Anova (analysis of Variance), T-tests analysis for comparing means of equivalent processes, determining significance of interaction between variables, Sample Size Calculation for experiments to meet ISO13485 requirements (with Minitab), setting up control charts for production, FMEA, Design of Experiment (DOE) for process changes and new process studies standards, Tools, Software IQ, OQ, PQs for ISO 13485 requirements on new equipment and tools for production JMP, Spotfire, Minitab, Excel Cross-Team Communication Technology transfer engineer The go-between for R&D and manufacturing when scaling up production Communication between software and manufacturing for software improvement and software validation

Timeline

STAFF Microarrays Validation Engineer

Agilent Technologies
02.2016 - Current

Staff Process Engineer

Complete Genomics
03.2011 - 10.2015

Senior Process Engineer

JSRMicro
03.2007 - 03.2011

Process Development Engineer

Cypress Semiconductor
05.2005 - 03.2007

Master of Science - Chemical Engineering

U.S.C

Bachelor of Science - Chemical Engineering

University of Tehran
Roya MOJTAHEDI