Gerardo Alejandro Segovia

E-mail: ac629v@r.postjobfree.com 1010 Ingram Road #7102 San Antonio, TX. 78245 Phone: (915-***-**-**

Objective

Obtain a professional Engineering position in a company where I can continue developing my professional career utilizing and applying my knowledge, management skills, as well as my ample experience and background as an Engineer where my analytical skills and critical thinking can be applied to solve modern problems. Core Competencies

Professional Engineer with 5+ years of experience, and strong work ethic. Project Leader Advanced knowledge in 21 CFR Part 11 compliance Project Management Minitab

Strong leadership Solid Works

Equipment and Software validation expertise AutoCAD Applied Statistical knowledge Master Control (CR BARD ERP) EOF and DOE applied expertise MFG Pro (CR Bard financial system) Documentation Expert (IQ, OQ, PQ, TMV) cPDM (Johnson & Johnson ERP system) Advanced Packaging knowledge Basic PLC Programming Advanced ETQ knowledge in CAPA and NC’s Microsoft Project PFMEA Creation Vision System Insight (Cognex) programming Failure Investigation Analysis Microsoft Office

Corrective and Preventive Action Plan assessment Bilingual Applied knowledge of ASTM in packaging products (pouches, trays and header bags):

- F2096-11 (Bubble Leak)

- F1929 (Dye Penetration),

- F2054 (Burst Test),

- D4541 (Pull off Strength)

Education

Electro-Mechanical Engineer – Universidad Tecnológica de Ciudad Juárez, México 2008-2013 Project Management Training – Jason Farley, Bridge Gap Consulting 2013 Johnson & Johnson QE Certification Program 2018

Professional Experience

Sr. Manufacturing Engineer – Biomedical Enterprises DePuy Synthes, San Antonio, TX. Oct 2017– Present

- CAPA and Non-Conformances owner.

o Lead process improvements to reduce non-conformances. o Lead NC and CAPA investigation and root cause analysis. o Coordinate R&D, QA, Production and Engineering department non-conformance investigations.

- Manage and lead increase of process capability by 20% in four EDM machines by updating the cutting parameters of the implants.

- Execute complete validation of EDM process improvement (IQ, OQ and PQ’s).

- Improve fixtures to decrease process fallout and scrap material by 30%.

- In charge of sustaining engineering activities.

- Validate Zebra printer to increase labeling process capability.

- Validate new spreading fixture to improve spreading process throughout all implant families.

- Perform validations for new components.

Sr. Validation Engineer–BWI Johnson & Johnson, Ciudad Juarez, Chihuahua, Mexico. Oct, 2014– Oct, 2017

- Manage and lead the development and validation of the semi-automated packaging inspection equipment to inspect the sealed areas of the pouches, header bags, sealed blisters and labeling control system to avoid mixed lots or products.

- Mange, lead and execute the development, integration and validation to innovate Laser Welder inspection to automate and reduce operation downtime by 80% by adding vision system Cognex cameras into the welder and reduce headcount fusing two operations into one.

- Advanced knowledge and application of 21 CFR Part 11 compliance applied to software validation requirements.

Gerardo Alejandro Segovia

E-mail: ac629v@r.postjobfree.com 1010 Ingram Road #7102 San Antonio, TX. 78245 Phone: (915-***-**-**

- Develop the EOF and DOE for bar sealers and generate the corresponding documentation activities (IQ, OQ, PQ) for the validation of the sealers to be deployed in production lines.

- Advanced knowledge and experience in software validations (CSV).

- EOF and DOE Analysis to determine optimal functionality of the equipment.

- Documentation Specialist responsible of creating all the required documentation for the validation activities (MOP, EPR, BOM, Routings, Protocols, Reports, Engineering Studies, IQ, OQ, PQ, TMV’s).

- Develop, analyze and create business cases for CIP projects.

- Identify innovation projects (robust process).

- Assist new product introduction team for the implementation of new production lines.

- Assist in the development, review and approval of equipment qualification, performance qualification, and process validation.

- Follow up and carry on validation executions.

Project/Validation Engineer–CR Bard, Cd. Juárez, Chihuahua, México May, 2012– Oct, 2014

- New project development team in charge of coordinating validation/verification activities for the implementation of new products.

- Responsible for $500K cost improvement project, managing the implementation of a Multivac assembly machine for the validation of 12 new product codes to increase production by a 40% in the validated codes and introduce new codes to work as a center of excellence and distribution of CR Bard pouches used in Reynosa and Nogales facilities.

- Lead the analysis and validation execution of a $160K cost improvement project, which consisted on evaluating materials and locate new supplier to improve quality and reduce material cost by 20% through standardization to use the same material on similar products.

- Analyze and complete the validation of vision systems for labeling control to the company, increasing quality assurance to the packed products and reduce costumer complaints.

- Lead a standardization project to align the software validation procedures of the facility in order to comply with 21 CFR Part 11 and coordinate the verification of 21 production line software to ensure the compliance with the stated requirements.

- Reduce Multivac assembly line production scrap by 50%.

- In charge of equipment qualification and test runs evaluation.

- Perform EOF to define parameter limits in order to perform DOE analysis of every validation to verify machine capability on every introduced product.

- Responsible for sealed product manufacturing lines (Multivac Assembly lines) and new product validations.

- Advanced knowledge in Multivac and Doboi sealers.

- Lead innovation activities and coordinate the implementation to increase process capabilities.

- Provide the necessary support on manufacturing lines.

- In charge of software verification and improvements.

- Creation of validation plans, protocol and summaries (MVP, IQ, OQ and PQ). Quality Assurance Engineer – AVJ Electronics. Cd. Juárez, Chihuahua, México Aug, 2010 – May, 2012

- Leader of Quality inspection area.

- Responsible for coordinating QC inspectors to complete facility priorities.

- Responsible for manufacturing process audits, in order to verify the quality of the manufactured products, create a report of the findings and possible corrective/preventive actions.

- Responsible for software testing and audits and coordinate manufacturing, IT and manufacturing teams to diminish the errors found during the audits.

Maintenance Engineer – AVJ Electronics, Cd. Juárez, Chihuahua, México May, 2010 – Aug, 2010

- Improve the end of line manufacturing flow by implementing conveyors reducing bottle neck.

- Responsible for the general maintenance of the manufacturing lines.

- Responsible of creating fixtures to improve the manufacturing process and lower human errors.

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