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Engineer Manager

Santo Domingo, Distrito Nacional, Dominican Republic
February 07, 2018

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***, ******* ******** ***** ******

Santo Domingo, Dominican Republic

Post Code: 10103

Marital Status: married

ID card: 001-*******-6


m:829 *** ****ópez-


Goals: Design, plan and manage

projects, optimizing processes,

resources, goods and services focusing

on the vision, mission and values of the

company, providing corrective and

preventive actions to any situation

presented in order to achieve the best



1. Experience in the Medical

Device and/or Pharmaceutical


2. Knowledge of validation

requirements for Medical

Devices, Pharmaceuticals and/or

regulated industry.

3. Experience leading technical

teams and mentoring less senior


4. Knowledge of Six

Sigma/Process Excellence tools

and methodologies (DMAIC,

DMADV, Lean), including Design


Senior Supplier Quality Engineer, Fenix Manufacturing Solutions

Santo Domingo 2017

Senior Quality Process Engineer, CLARO RD

Santo Domingo 2017

Evolution project OSS (Operational System Support).


Senior Engineer, Edwards LifeSciences

Haina, San Cristobal Temporal agreement

Leading validation and re-validation of equipment and process protocols related to changes of materials, suppliers.

Compose IQ, OQ & PQ opening and closure reports. Coordinate the execution of the protocols. Assign and follow up executors activities. Coordinate Overtime if is required.

Propose and implement improvements to processes and equipment.

Lead projects of introduction of new products. Manage and assure the up to date of the project plan. Keep actualize deliverable board to management meetings.

Support in regulatory changes and product labelling schemes. Lean Six Sigma Analyst, Laboratorios Rowe, S.R.L.

Pantoja, Santo Domingo 2015-2016

Work with project engineering personnel, R&D, regulatory and QA to ensure requirements related to tableting, coating and capsule encapsulation processing activities are met.

Product Development R&D.


Six Sigma.

Validation Analyst, Laboratorios Rowe, S.R.L.

Pantoja, Santo Domingo 2011-2015

Prepare and execute qualification protocols and reports for equipment, computerized system and utilities.

Participate in the execution of the re-qualification programs as per established procedures and timelines.

Ensure that protocols and reports comply with established corporate standards and cGMP regulations.

Ensuring that project deliverables meet internal procedures and client requirements.

Provide validation support during the installation, start up and of Experiments, capability

analysis, sampling statistics and

techniques, CTQ flow down,

Prioritization Matrix, PFMEA,

and/or C/E fish bone diagrams.

5. The ability to select and execute

the appropriate statistical tools

and provide the practical

conclusions and inferences

during process development and

validation activities.

6. The ability to collaborate

effectively with all levels of

management and influence

decision-making across a matrix


7. Hands-on experience in writing

qualification documents and

engineering studies.

8. Strong interpersonal skills and

ability to work effectively within a


9. Detail oriented and analytical

problem solving skills.

10. Quality Risk Management

Process Improvement

11. Statistics

12. Projects

13. Validation (IQ, OQ, PQ)

14. Microsoft Visio

15. Auto Cad

16. Minitab

17. SolidWorks

18. Graphing

19. AS-400

20. Axapta (Microsoft Dynamics)

21. SQL


23. MSA

24. FMEA

25. GRR

26. Gauge

production for new and existing equipment and systems.

Project coordinator using DFSS and DMAIC methodology.

Validate measurement system.

Products transfer.

Commissioning and FAT.

Develop a documented evidence of the quality of the manufactured products during the validation process.

Create procedures (SOP) for handling production equipment and instruments for calibration.

Supervising calibrations performed by external/internal suppliers to ensure that instruments are properly calibrated and identified. Project Engineering Intern, Fenwal Blood Technologies, Inc.

Haina, San Cristobal 2010-2011

Run validation protocols for products from the Puerto Rico facility complying with the Standards of Good Manufacturing Practices

(GMP) and Good Documentation Practices (GDP) of the Industrial and Manufacturing System.

Supervise production operations in Manufacturing Production lines under validation, coordinating the appropriate use of personnel under my care, equipment (Rotary Machine) and materials necessary to achieve the objectives of quality and quantity of production, according to the standards defined in the organization.

Demonstrate that the process will produce acceptable results and establishment of limits (worst case) of the process parameters. Maintenance Mechanic, INMECA (Instalaciones Mecánicas del Caribe)

Quita Sueño, San Cristóbal 2008-2010

Assigned to performing the program maintenance of production equipment.

Assist the maintenance engineer to schedule maintenance activities.

Supervisor and Payroll Manager, López Paulino y

Asociados, C. x A.

Santo Domingo, Distrito Nacional 2005-2006

Responsible for purchasing materials, supervising the activities of the building program and staff under me. Responsible for preparing payroll for a construction company civil and steel structure. EDUCATION

Barcelona European Business School, ENEB

Currently attending the Master in Project Management present Lean Sigma Solutions

Six Sigma Black Belt training, Design for Six Sigma training 2015 IESATEC Virtual, S. R. L.

Design of Experiments, Quality Engineer training, Six Sigma Green Belt, SPC, Quality Risk Management 2014

Autonomous University of Santo Domingo (UASD)

Bachelor of Science Industrial Engineering 2012

OSCUS San Valero Foundation

Logistics 2011

National Institute of Technical and Vocational Training


Diploma in Quality Management Systems ISO 9001-2008: Introduction to Management System ISO 9001 Quality, Documentation Coordinator ISO 9001, Internal Auditor ISO 9001 and Implementation projects Coordinator. 2011

National Institute of Technical and Vocational Training


Industrial Mechanics, Basic Industrial Maintenance Mechanics, Total Productive Maintenance, JIT strategies, Improvement of Methods. 2008


DFSS - DoE Improving High Speed Pharmaceutical Powder Compression, Mega Pharma (Laboratorios Rowe, S.R.L.) Pantoja 2015

Systematic application of QfD and DfSS principles to 2 families of low flow pharmaceutical powder and granules across product development, quality and manufacturing functions.

Achieve, through cost-effective and time-sensitive DoE and SPC, optimal mixing / manufacturing parameters for high speed tablet compression (>70k tables/min).

40% reduction of manufacturing lot size.

55% improvement in production throughput.

Improvement six sigma level process performance (Pp) and process capability (Cp) indexes.

Allowing for significant participation in a USD$20M oncological treatment drug market.

Six Sigma project to enhance capability, Mega Pharma

(Laboratorios Rowe, S.R.L.)

Pantoja 2015

Savings of USD$80k on Six Sigma project to enhance capability in order to meet regulatory requirements. Sealing Project, Mega Pharma (Laboratorios Rowe, S.R.L.) Pantoja 2015

Savings of USD$58k using DMAIC methodology to reduce cost due to customer dissatisfaction on failure sealing test. REFERENCES\

Raysa Perez Riley Alvarez Félix Hidalgo

Services Manager Project Manager Finance Manager

Rowe Laboratory Amadita Laboratory PROPAGAS

Work: 809 *** **** Mobile: 809 *** **** Mobile: 829 *** **** Mobile: 829 *** ****

Raymond Alberto

Operational Excellence Manager


Mobile: +1 787 *** ****

Available upon request.

Contact this candidate