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Engineer Manufacturing

Location:
Nanuet, New York, United States
Salary:
80,000
Posted:
December 23, 2018

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Resume:

EVELYN RODRIGUEZ

** *** ******* *******

Nanuet, NY 10954

914-***-****

SUMMARY

Provide process development support and lead commercialization initiatives for new products.

Strong interpersonal, communication and problem-solving skills.

Equipment servicing & troubleshooting.

Specialty in encapsulation technologies (spray dry, emulsions, and extrusion)

Follow technical transfer of new developments from bench top, pilot plant, to upscale and final production (commercialization).

Attention to detail in regards to product quality and performance standards.

PROFESSIONAL EXPERIENCE

Cosmetic Essence Inc., Ridgefield, NJ

Process Engineer 4/2017-Present

Primary technical lead between Research & Development and Compounding and the Quality units. My position serves as a key resource to ensure manufacturing processes are compliant with internal and external requirements by monitoring the transfer of all pilot, first production and all new lab batch sizes from Research & Development to commercial manufacturing and to ensure the smooth transition from R&D to commercial production.

Observe R&D batches of new products when being made for PLTR (Product Launch Testing Requirements). Record detailed manufacturing instructions and observations as batches are being made to convert manufacturing instructions for compounding.

Write and/or reviewing manufacturing instructions for compounding, including safety procedures for any hazardous material handling.

Supervise all pilot batches, providing guidance and knowledge transfer to compounding personnel in processing procedures and equipment choices, resulting in high quality product, meeting all pre-determined quantitative specifications and qualitative properties.

Amend any procedures as noted during the pilot or first production batches to update compounding instructions.

Monitor processing procedures to understand the critical control points to avoid quality issues and/or to reduce the hazard to an acceptable level using processing techniques.

Perform gap analysis of critical processing elements to further improve batch cycle times and overall continuous improvements as they relate to quality and efficiencies.

Perform and/or monitor in-process checks during manufacturing to assure product quality conforms to all quantitative specifications and all qualitative (aesthetic and textural) properties.

Conduct process data analysis, driving continuous improvement in product and process development in manufacturing, leading OOS and quality investigations, and providing timely communication and guidance to direct management.

Attend Production meetings to provide input and guidance to scheduling and batch processing capabilities to ensure the highest quality product that meets all parameters.

Update all manufacturing instructions for current products produced in manufacturing. Revise records when / as needed.

Supervise Pilot and First Production, new tank/batch sizes, and validation batches for all products (inclusive of OTC) or customer requested validations.

Monitor and assist in the transfer of bulk to Production Filling, including writing transfer/filling instructions in conjunction with R&D.

Monitor and assist in the Filling Validation procedures for bulk produced under Validation Conditions.

Collaborate with QC to test bulk and finished products prepared under Validation conditions and prepare final reports.

Serve as backup to Senior QA/QC chemist in releasing daily bulk production as needed.

Write/update SOP’s (Standard Operating Procedures) and/or work instructions for Technology Transfer procedures.

Maintain bulk history data using APR (Annual Product Review) software and issuing reports to management.

Maintain Batch Cycle Time data for all production batches, and critical key performance indicators.

Maintain adherence to cGMP’s (current Good Manufacturing Practices) and SOP’s (Standard Operating Procedures) for the cosmetic/personal care industry.

Perform other related duties as assigned.

SKILLS & ABILITIES

Working knowledge of manufacturing equipment: including but not limited to: pumps, mills, in-line/in-tank homogenizers, various mix tanks (prop, sweep, vacuum, etc.)

Knowledgeable in operating lab equipment: including but not limited to: Viscometers, pH Meters, Density Meters/Pycnometers, etc.

Scientific Math Aptitude/Strong Analytical Skills.

Has advanced knowledge and understanding of commonly used concepts, practices and procedures within the field: cGMPs, ICH Guidelines, FDA standards, OTC regulations, etc.

Capable of following all required SOP’s (Standard Operating Procedures) and safety programs.

Ability to exercise independent and proper judgment and initiative.

Excellent oral, written and interpersonal communication skills.

Organized and efficient in time management skills.

Ability to organize and manage multiple priorities.

Computer literate in Microsoft Excel, Outlook, Word and Access.

Ability to work independently.

Kolmar Laboratories, Port Jervis, NY

Process Engineer 6/2016-4/2017

Develop and implement efficient manufacturing, assembly procedures for new products, and provide technical assistance to existing ones.

Review customer's specifications and ensure requirements are met.

Make necessary adjustments to pilot batches to ensure product quality.

Identify and interpret variation in products, equipment, and processes which may affect results.

Work with manufacturing and production personnel on setting specs for pilot batches and fill trials of new products, and accurately record results.

Execute 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

Overall Supplier Management Process to ensure performance and controls are adequate to meet company's objectives.

Coordinate with Strategic Sourcing to jointly qualify new suppliers, and periodically audit existing ones.

Lead completion and publication of Suppliers Score Cards.

Analyze and improve supplier performance through implementation of corrective actions or quality plans to prevent repeat non-conformances.

Responsible for follow up NCMD. CAPA, PMR's. Follow up with root cause investigation.

Support internal/external audits as per QMS specifications for completion and compliance.

Revision of SOP's and initiate required updates for compliance.

Lead bi-weekly conference calls with Low Cost Region suppliers (India/China) for updates related to material quality and performance.

Follow 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)

Establish open innovation network for problem solving against difficult-to-process new innovative forms

Work with external manufacturing partners for related development efforts for unit operations associated with production of innovative forms

Generate, document and execute 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).

Plan and execute tests of new equipment and technologies to ensure products can be manufactured in the Sun Products Corporation manufacturing network.

Collaborate with R&D teams to develop raw materials, equipment and process for innovative forms technologies applied to laundry and cleaning

Communicate status of work to appropriate parties in order to keep them informed and involved.

Generate a plan and timeline to commercialize a new product.

Create technology transfer documentation / visualization for cross functional technical communication and training purposes during commercialization

Conduct 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.

Serve 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

Runs and troubleshoots powder/liquid mixing & blending methods, emulsification & homogenization technology, spray-drying and the flavor extrusion process.

Plans and executes lab experiments and corresponding analysis and pilot-scale processes.

Solves technical problems related to spray-dry emulsions and emulsion stability.

Develops prototype flavor encapsulation (Evoglass) products for customer presentation and sample submission.

Supports Evoglass platform in all its analytical and technical aspects.

Assists internal customers in solving product and production related problems.

B. Pilot & Production Scale-up

Assists 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.

Provides on-site coverage for first time production in Branchburg, Teterboro, and Elyria as required.

Provides on-site support for investigation of production issues and optimization of processes for existing product portfolio.

Works directly with internal and external customers in product development, optimization and troubleshooting and finding technical solutions for extrusion, blending, spray drying, reactions and emulsification.

Recommends change of processing parameters and mixing instructions, when necessary.

Interacts with Quality Control on setting up and/or modifying specifications.

Monitors experiments for future data collection and exchange of information with supervisor or colleagues.

C. Service & Maintenance

Establish 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.

Looks continuously for improvements of existing procedures, methods and equipment.

D. Training & Procedures

Conducts all training on small extruder.

Trains laboratory personnel in correct application of developed techniques and methodologies.

Supervises and trains production personnel on new processes and/or products

Siemens Medical Diagnostics Solutions, Tarrytown, NY 3/2007- 10/2007

Field Service Engineer

Installation/Maintenance/Repair/Calibration/Troubleshooting of Medical Diagnostics Equipment such as: Blood Gases, Blood Chemistry, Hematology, and Urinalysis.

Investigation of 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)

Create project timelines and key milestones for assigned project and update it based on progress of projects.

Create and use 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.

Assist in the preparation of project proposals by providing information specific to order supplies, packaging, shipment, and distribution techniques.

Effectively apply 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).

Assessment of processes for their relevance, and assessing the adequacy of process equipment;

Review existing data (also lab analysis) to see if more research and information need to be collated after final product obtained as per batch records.

Design, installing and commissioning new production units, monitoring modifications and upgrades, and troubleshooting existing processes;

Conduct process development experiments to scale in a laboratory;

Prepare reports, flow diagrams and charts;

Assessment the availability of raw materials and the safety and environmental impact of the plant.

Managing the cost and time constraints of projects;

Supporting the conversion of small-scale processes into commercially viable large-scale operations;

Work closely with production to monitor and improve the efficiency, output and safety of a plant.

Ensure the process works at the optimum level, to the right rate and quality of output, in order to meet customer needs.

Make observations and taking measurements directly, as well as collecting and interpreting data from the other technical and operating staff involved.

Keep track of environmental monitoring and ongoing performance of processes and process plant.

Ensure 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.

EDUCATION

Catholic University of Puerto Rico, Ponce, Puerto Rico

Bachelor of Science in Biology/Pre-Medics

CERTIFICATIONS

Mobile Flow School (Ultra-pure water systems expertise) 4/21/03

Microsoft Project Management 6/22/05

Heartsaver AED First Responder 05/26/14

Spray Dryer Technology 03/2014



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