Quality Assurance Process Engineer
Resume:
EVELYN RODRIGUEZ
Nanuet, NY *****
Objective:
I am an experienced professional seeking a role that allows me to utilize my experience and knowledge in process, manufacturing, quality, and problem-solving field to address complex challenges and drive technological advances while assuring the delivery of products to consumers meeting higher standards in quality.
SKILLS:
cGMP/ GCP / GLP
R&D
Process/manufacturing Engineering and Tech Transfer
Quality Assurance/Control documentation (QMS, CAPA, CC, NCMR, Root cause Analysis)
Analytical Laboratory Instrumentation
Supervising experience/Leadership
Project Management
Bilingual (English/Spanish)-Fluent
SAP
Microsoft Outlook
Microsoft Excel
Visio
Power Point/SharePoint
PMP
PROFESSIONAL EXPERIENCE:
Kawasaki Rail Car - Yonkers, NY 07/2024-09/2024
Supplier Quality Engineer
Responsible for developing, implementing, and maintaining quality assurance protocols to ensure supplier compliance and product quality.
Develop and implement supplier quality evaluation and control systems
Monitor, communicate and improve tracking of non-conforming material thru MRB daily meetings.
Work with internal and external teams to resolve supplier quality issues
Collaborate with supplier representatives on quality problems, ensure corrective actions are implemented and contribute to supplier quality improvement programs
Manage and maintain supplier performance metrics, assessment, and certification programs
Work with suppliers to execute specific quality system processes
Coordinate with engineering and procurement teams to ensure supplier compliance with contractual requirements
Strides Pharma, Ltd.- Chestnut Ridge, NY. 02/2024-05/2024
Process Engineer I
Lead and execute lifecycle activities from start to end for solid oral dosage, liquid, powder filling, soft gel and semi solid form manufacturing including evaluation, validation, scale up, and lifecycle changes.
Analyze statistical data from qualification, product or functional specifications to determine conformance with standards and established quality requirements.
Write and execute experimental and validation protocols as per related SOPs and assure that acceptance criterion related to experimental and validation protocols are met.
Write and execute experimental and validation reports as per related SOPs and assure that acceptance criterion related to experimental and validation reports are met.
Assist with initiating change control for new products, site transfer products and changes related to the process improvement with appropriate justification.
Lead investigations, write investigation reports with appropriate scientific understanding, as required upon failures to meet protocol acceptance criteria.
Urban Electric Power - Pearl River, NY 03/2023 – 11/2023
Sr. Manufacturing Engineer
Responsible for determining, developing, and improving operations to produce zinc cells and ensure process definition and documentation including parameter set up and optimization on assembly equipment, e.g., precision resistance welders, ultrasonic welders, mixing equipment and roll-to-roll manufacturing.
Ensured quality, cost and efficiency requirements are met.
Troubleshooted problems with production and takes corrective action. The process engineer also researches the repair of machinery, the purchase of new equipment and tooling or upgrades to existing equipment
Evaluated, implemented and monitored processes and operating systems for the manufacture of cells and batteries.
Created/edited/maintained necessary documentation, including writing and updating work instructions and operating procedures.
Monitored and improved the efficiency, output and safety of manufacturing processes through observations and measurements as well as by collecting and interpreting data from other technical and operating personnel.
Worked closely with other specialists (R&D) to ensure proper quality assurance compliance and methods.
Assessed materials and their safety and environmental impact on the facility
Worked to continuously improve in all areas using LEAN Manufacturing principles.
Helped manage departmental performance measures, including visual controls and provide regular progress reports to manager.
Provided leadership through example and adherence to policies.
Communicated issues and priorities to supervisor on a regular basis and to other management as requested.
Acuitive Technologies - Allendale, NJ 05/2022-11/2022
Manufacturing Engineer
Ensured successful design transfer to manufacturing and lead IQ, OQ, PQ to meet time to market product and new launch requirements.
Supported production engineers and technicians to ensure product quality, delivery, and cost to meet or exceed customer expectations.
Supported QC/QA initiatives for orthopedic implants NPD.
C16 Biosciences - Pearl River, NY 06/2021 –05/ 2022
Process Technologist
Supported activities related to operation, maintenance, and continuous improvements of new sample generation facility (Pilot Plant).
Facilitated transfer (scale up) of novel processes developed at Lab.
Developed SOPs for process equipment and downstream process unit operations.
Monitored critical process parameters and troubleshoot equipment during process as needed.
Managed the day-to-day maintenance activities in the Pilot Plant.
Analyzed process samples using various instruments such as: OD600, Moisture Content Analyzer, HPLC, etc.
Maintained accurate and detailed batch records and data.
Operated and maintain in good working condition pilot scale equipment.
Interacted at all levels of the organization and work with external partners (contractors, equipment vendors, and facility service providers) for services and maintenance.
Reviewed data and analytics to make continuous improvements at scale as needed.
Complied with safety, quality, policies and procedures (SOP's and Process Transfer).
Bentley Laboratories, LLC - Clifton, NJ 12/2020 – 06/ 2021
Compounding Manager/Process Engineer
Role and Responsibilities:
Managed the interfaced with all support organizations to convert pre-weighed orders into perfectly produced bulk batches that are produced, in-process evaluated, sampled and tested, and approved to drop into approved packaging, stored for final approval and release to bulk-only customers or for filling.
Consolidated bulk manufacturing, BPD engineering, and bulk QC into one Area, with a single owner responsible for managing the safety, quality, operation of equipment, and personnel dedicated to this area, delivering bulk batches that meet or exceed our customer's expectations.
Created and maintained standard operating procedures and metrics to ensure high quality execution of the Area to meet or exceed customer expectations.
Worked closely with R&D, the Ingredients and Pre-Weigh, Planning, and Cleaning & Sanitization Teams to understand bulk order priorities, technical complexity, equipment availability, tools and tool cleanliness, and to ensure QC facilities are all functional and reliable.
Achieved the financial performance for the area and meet all targets while managing operating spending against budget, overtime management, and compliance to expected outputs measured by batches produced, batches meeting specifications, and approved for customer use on time and at cost.
Enforced and maintained safe operational practices to protect our employees from personal harm, and ensure compliance with our safety and environmental rules, regulations and procedures.
Identify, prioritize and pursue continuous improvement projects in the area.
Effectively planned and managed resources to execute orders in the area, securing direct and temporary employees as needed, and manage the training, development and performance of all employees in the area.
Maintained and executed the planning and scheduling of all manufacturing batches and ensure timely and data driven reporting to meet the requirements of other departments and business team planning personnel.
Actively participate in investigations, recommend and implement corrective actions, and proactively gather the company's technical resources when needed.
Built a solid understanding of all operational processes and maintain a strong working relationship with other Area Managers, sales, planning, operations, HR, Finance and R&D partners.
Led by example, and create a collaborative team environment within the Area, by prioritizing workloads, focusing the team members on critical requirement, reward, recognize, and mentor each member to deliver the results expected.
Successfully scale-up new products transitioning from R&D, including process technologies to employ, ensuring safe procedures, setting critical processing parameters, and moving products from tentative specifications to full commercial specifications within our processing capabilities
IMCDUS - Rochelle Park, NJ 06 2019-12/2020
Pharma Technical Center Scientist
Summary of Responsibilities:
Managed day-to-day operation of the Customer Collaboration Center (C3 IMCD), including laboratory processing equipment, raw materials, and facility following GLP's, quality, and regulatory requirements.
Delivered training and demonstrations for Sales and Technical Marketing personnel of IMCD in accordance to the standards as laid out by the Regional Technical Director - Pharmaceutical
Essential Functions:
Managed laboratory processing equipment, raw materials, and facility according to current health and safety, quality, and regulatory requirements.
Supported preparation of laboratory trainings and demonstrations for Sales and Technical Marketing personnel of IMCD US.
Led technical workshops and give presentations without supervision.
Undertakes application and product development studies for internal marketing purposes and customer projects, as required.
Supported Technical Marketing group in their key project activities in Americas.
Executed projects related to Oral Solid Dosage and Topical Manufacturing Technologies such as blending, compression (Piccola Tablet Press), pan coating (O'Hara Lab Coater), fluid bed (Glatt), homogenizers, and mixers.
Cosmetic Essence Inc., Ridgefield, NJ
Process Engineer 4/2017-6/2019
Developed and implement efficient manufacturing, assembly procedures for new products, and provide technical assistance to existing ones.
Reviewed customer's specifications and ensure requirements are met.
Made necessary adjustments to pilot batches to ensure product quality (Reworks).
Identified and interpret variation in products, equipment, and processes which may affect results.
Worked with manufacturing and production personnel on setting specs for pilot batches and fill trials of new products, and accurately record results.
Executed fill trial with customers on site and transfer all technology details to manufacturing.
Kolmar Laboratories, Port Jervis, NY
Process Engineer 6/2016-4/2017
Developed and implemented efficient manufacturing, assembly procedures for new products, and provide technical assistance to existing ones.
Reviewed customer's specifications and ensure requirements are met.
Made necessary adjustments to pilot batches to ensure product quality.
Identified and interpret variation in products, equipment, and processes which may affect results.
Worked with manufacturing and production personnel on setting specs for pilot batches and fill trials of new products, and accurately record results.
Executed fill trial with customers on site and transfer all technology details to manufacturing.
Thermo Fisher Scientific, Fair Lawn NJ
Supplier Quality Engineer 04/2015-06/2016
Effectively followed Supplier Management Process to ensure performance and controls are adequate to meet company's objectives.
Coordinated with Strategic Sourcing to jointly qualify new suppliers, and periodically audit existing ones.
Led completion and publication of Suppliers Score Cards.
Analyzed and improved supplier performance through implementation of corrective actions or quality plans to prevent repeat non-conformances.
Followed up NCMD. CAPA, PMR's. Follow up with root cause investigation.
Supported internal/external audits as per QMS specifications for completion and compliance.
Revised SOP's and initiate required updates for compliance.
Led bi-weekly conference calls with Low-Cost Region suppliers (India/China) for updates related to material quality and performance.
Followed up customer's complaints through investigation through resolution.
Liaison for Quality Control assurance of manufacturing processes including current validation and documentation through interaction with various departments such as: QC Lab, Ops, Supply Chain, and Production.
Sun Products Corp., Trumbull CT. 06/2014-04/2015
Process Engineer (R&D)
Established open innovation network for problem solving against difficult-to-process new innovative forms
Worked with external manufacturing partners for related development efforts for unit operations associated with production of innovative forms
Generated, documented and executed a plan to select and/or develop technology (e.g., order of addition, chemical interactions, processing parameters, processing equipment) including managing dynamic timelines, in order to meet the project's specific objectives (e.g., improve quality, deliver new products, optimize processes).
Planned and executed tests of new equipment and technologies to ensure products can be manufactured in the Sun Products Corporation manufacturing network.
Collaborated with R&D teams to develop raw materials, equipment and process for innovative forms technologies applied to laundry and cleaning
Generated a plan and timeline to commercialize a new product.
Created technology transfer documentation / visualization for cross functional technical communication and training purposes during commercialization
Conducted field tests to gather data (e.g., processing capability, equipment needs, formulation restriction) in order to improve manufacturing feasibility, product performance, and/or product quality.
Served as a technical liaison for all levels including production /maintenance, plant technical and management resources, corporate engineering and R&D organization, and other plants.
Symrise Inc., Teterboro NJ 10/2007-06/2014
Associate, Process Engineering
A. Lab Sample Development
Managed and troubleshooted powder/liquid mixing & blending methods, emulsification & homogenization technology, spray-drying and the flavor extrusion process.
Planned and executed lab experiments and corresponding analysis and pilot-scale processes.
Solved technical problems related to spray-dry emulsions and emulsion stability.
Developed prototype flavor encapsulation (Evoglass) products for customer presentation and sample submission.
Supported Evoglass platform in all its analytical and technical aspects.
B. Pilot & Production Scale-up
Assisted with the transfer of new products and processes into manufacturing across all product formats as well as optimization of production on the large extruder, spray dryers, reactors or blenders/mixing tanks.
Provided on-site coverage for first time production in Branchburg, Teterboro, and Elyria as required.
Provided on-site support for investigation of production issues and optimization of processes for existing product portfolio.
Worked directly with internal and external customers in product development, optimization and troubleshooting and finding technical solutions for extrusion, blending, spray drying, reactions and emulsification.
Recommended change of processing parameters and mixing instructions, when necessary.
Interacted with Quality Control on setting up and/or modifying specifications.
Monitored experiments for future data collection and exchange of information with supervisor or colleagues.
C. Service & Maintenance
Established knowledge to run and service lab and pilot plant equipment, i.e. homogenizers, mixers, spray dryers, pasteurization units and other manufacturing processes and analytical equipment.
Continuously looked and researched for improvements of existing procedures, methods and equipment.
D. Training & Procedures
Conducted all training on small extruder.
Trained laboratory personnel in correct application of developed techniques and methodologies.
Supervised and trained production personnel on new processes and/or products
Siemens Medical Diagnostics Solutions, Tarrytown, NY 3/2007- 10/2007
Field Service Engineer
Installed/Maintained/Repaired/Calibrated/Troubleshooted Medical Diagnostics Equipment such as: Blood Gases, Blood Chemistry, Hematology, and Urinalysis.
Investigated unusual / unacceptable results /data interpretation for proper troubleshooting assessment and proper customer service.
Aptuit, Inc., Allendale, NJ 6/2005 - 3/2007
Project Manager, Clinical Packaging & Logistics (Kelly Services Temp. Agency)
Created project timelines and key milestones for assigned project and update it based on progress of projects.
Created and used Gantt charts, spreadsheets or other appropriate tools to manage project until completion
Oversee daily operations regarding timely delivery of clinical supplies to be used in packaging and distribution for clinical trials, including protocol review and inventory management in accordance with cGMP's, GCP's and SOP's.
Assisted in the preparation of project proposals by providing information specific to order supplies, packaging, shipment, and distribution techniques.
Effectively applied company methodology and standards for project development to effectively demonstrate professional leadership and commitment to company values.
Purdue Pharmaceuticals; Ardsley, NY 10/2002 – 5/2005
Sr. Chemical Processing Engineer/Pilot Plant/Chemical Development (R&D)
Responsible of the daily operation, maintenance, calibration and assembly of a variety of R&D pilot upscale chemical processing equipment (reaction reactors, distillation equipment, dryers, mills, and filtration).
Assessed of processes for their relevance, and assessing the adequacy of process equipment;
Reviewed existing data (also lab analysis) to see if more research and information need to be collated after final product obtained as per batch records.
Designed, installed and commissioned new production units, monitoring modifications and upgrades, and troubleshooting existing processes;
Conducted process development experiments to scale in a laboratory;
Prepared reports, flow diagrams and charts for data compilation.
Assessment the availability of raw materials and the safety and environmental impact of the plant.
Supported the conversion of small-scale processes into commercially viable large-scale operations;
Kept track of environmental monitoring and ongoing performance of processes and process plant.
Ensured that all aspects of an operation or process meet specified regulations.
Work closely with other specialists, including: scientists responsible for the quality control of raw materials, intermediates and finished products; engineers responsible for plant maintenance; commercial colleagues on product specifications and production schedules; and the operating crew.
Southern Company, Waynesboro, GA 6/1986 – 10/2002
Senior Nuclear Chemistry Technician/Senior Health Physics Technician (3.1)
Chemistry:
Perform radiochemistry analysis on samples taken across plant site to meet specifications for Nuclear Regulation: Liquid Scintillation, Beta/Gamma Count Room, ASTM for Diesel, Reactor Water Chemistry, Environmental (Cooling Towers Water), among others.
Run Water Treatment Plant (Demineralized Water Source) regularly and analyze samples to ensure quality of water.
Performed operation, maintenance, calibration standardization, and troubleshooting of analytical instrumentation such as HPLC, AA (expertise level), and IC, GC, Liquid Scintillation, CO2 monitor/Blood gases, Gamma Spec, pH meters, Turbidity meters, Viscometers, Flash Point, Specific Gravity, SiO2 analyzers, Mercaptan analyzers among others used for radiochemistry analysis.
Investigation of unusual / unacceptable results /data interpretation of nuclear activity Reactors water chemistry specifications.
EDUCATION:
Catholic University of Puerto Rico, Ponce, Puerto Rico
Bachelor of Science in Biology/Pre-Medics
CERTIFICATIONS:
Mobile Flow School (i.e. RO, Ultra-pure water systems expertise)
Microsoft Project Management
Spray Dryer Technology
DOT Hazardous Material Regulations
Hazardous Waste Management
DOT for Radiopharma
Radiation Safety
EPA Regulations (HAZMAT, Airbourne Particles Sampling, etc.)
Chemical SDS
cGMP, GLP, GXP, OTC, and Personal Care Certification.
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