1. Cesar Soto González
● Urb. Alt de Flamboyan ● Calle 6 B1 ●Bayamon PR. 00959 ● Mobile: 787-923-3446 ●E-mail: soto.gonzalez.cesar@gmail.com
QUALIFICATIONS
Skilled in troubleshooting techniques, test and setup in a variety of equipments. Experience working
with wiring diagrams, schematics and blue prints and mechanical expertise. Good communicator and
leader. Able to work under pressure with limited supervision. Proven ability to learn new technologies
quickly and thoroughly and pass on information in an effective manner. Resourceful team player
working with integrity and professionalism. Flexible and committed to company success.
CERTIFICATIONS / TECHNICAL SKILLS:
 Basic knowledge in Control System, Signal Processing, Automation System
 Knowledge in the following language programs: Matlab, C++and PSpice
 Literate in MS Windows; MS Applications (Word, Excel, Outlook, PowerPoint, Publisher, Visio);
IE/Chrome browser applications and AutoCad.
 Knowledge in pharmaceutical and GMP environment.
 Excellent verbal and written communication skills both English and Spanish
 Proactive, Self-Starter Highly Motivated, Leadership, Excellent Team Player, Goal-driven
 Technical/ Regulatory: Current Good Manufacturing Practices (cGMP), Good Documentation
Practice (GDP) and Good laboratory Practice (GLP) oriented.
 Knowledge in Trackwise, FactoryWorks, MiniTab, Adobe Photoshop, SAP,EQMS
PROFESSIONAL EXPERIENCE
Project Engineer – MGD Industrial at Medtronic Ponce, PR
Aug 2016 - Present
 Make changes to POD to implement new techniques in the process to improve manufacturing
operations.
 Implement new Product / Process activities across the facilities following Technology
Roadmaps and Design Engineering activities.
 Perform validation activities IQ, OQ, PQ
 Perform CAPA and Non-Conformance implementation activities
 Continually evaluated designs and processes for yield improvements and cost savings.
 Certified in PV & CSV.
 Performed product investigations in order to determine if it was conforming material or not.
 Developed, implemented, and maintained manufacturing documentation pertaining to part
specifications, work instructions, process flow maps, and quality control/quality assurance.
 Responsible for management and control of the financial tracking and savings of projects.
 Monitor financial data to ensure its accuracy in order to complete project within budget
restraints.

2. Manufacturing Engineer – ISO Group at Medtronic Juncos, PR
Aug 2015-May 2016
 Implement the currentprocess in manufacturing area.
 Includes daily support of production operations as well as leading reliability and yield
improvement activities for new products while handed off to the process owner.
 Make changes to POD to implement new techniques in the process to improve manufacturing
operations.
 Implement new Product / Process activities across the facilities following Technology
Roadmaps and Design Engineering activities.
 Perform validation activities IQ, OQ, PQ
 Perform CAPA and Non-Conformance implementation activities
 Continually evaluated designs and processes for yield improvements and cost savings.
 Developed and lead scrap reduction projects.
 Certified in PV & CSV.
 Performed product investigations in order to determine if it was conforming material or not.
 Developed, implemented, and maintained manufacturing documentation pertaining to part
specifications, work instructions, process flow maps, and quality control/quality assurance.
 Supervised and provided direct support to production personnel and any manufacturing issues
that developed, from equipment malfunction and material issues, to workmanship issues
Validation Engineer (De-Commissioning) – Development, Management & Consulting Group at
Merck Sharp & Dohme, Hatillo, PR
March 2014- June 2015
Provide logistic in the decommissioning of MSD Records Management for the QO, Safety, HR and
Finance departments. Review batch record elements (e.g., MP, PCR), Validation Protocols, Method
Transfer Protocols for their retention and holding times based on Legal Hold status.
 Acting Team Leader for the Critical Record Retention of the Quality Department and Analytical
Laboratory Records.
 Prepare inventory for the Master Archive retention list for documents to be retain by Merck in
Iron Mountain.
 Prepare the Master Archive Retention List for all documents retain by Merck.
 Prepare inventory for the destruction of documents past due there retention time not on Legal
Hold.
 Review document withheld in the QO Department to segregate between Validation, batch
records, Method Transfer, CAPA, and other GMP critical documents.
 Organize GMP, operational documents and segregate the documents by access and non-access
categories.

3.  Helped prepare decommissioning plan and checklists for execution of decommissioning of
electronic critical GMP equipment.
 Archive documents in the applicable retention areas based in current policies and SOPs.
 Instructed in training such as Safety and Environmental Health, GMP, Decommissioning
Processes, Record Retention and Gowning.
 Organize and coordinate record retention boxes movement to designated area.
 Keep documentation tracking of discarded document and obsolete or redundant digital media
according to SOP’S and internal policies.
 Submit a weekly progress report to Network Director and Decommissioning.
 Training new employee in procedures and guidelines of Decommissioning and Record
Retention
EDUCATION
Bachelor of Science in Electrical Engineering in Polytechnic University of Puerto Rico
Coursing Master Degree in Engineering Management whit a Major in Manufacturing
Engineer (Expected Graduation May 2017)