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Raul Soto

Senior Principal Software Engineer @ Johnson & Johnson Vision

Senior Principal Software Engineer at Johnson & Johnson Vision

Jacksonville, Florida Area

Ranked #595 out of 11,907 for Senior Principal Software Engineer in Florida

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Raul Soto's Email Addresses & Phone Numbers

Raul Soto's Work Experience

Johnson & Johnson Vision

Senior Principal Software Engineer

Jacksonville, Florida Area

KellyOCG

Operations/ Quality Systems and Validation Engineering Manager

December 2012 to March 2013

Johnson & Johnson

Principal Software Quality Engineer at Johnson & Johnson Vision Care

April 2013 to April 2018

Jacksonville, Florida Area

Raul Soto's Education

California State University

MS in Biotechnology and Bioinformatics, Biomedical Engineering

2010 to 2012

Universidad Politécnica de Puerto Rico

Bachelor of Science, Mechanical Engineering

1991 to 1994

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Raul Soto's Professional Skills Radar Chart

Based on our findings, Raul Soto is ...

Easygoing
Strong sense of self
Initiating

What's on Raul Soto's mind?

Based on our findings, Raul Soto is ...

50% Left Brained
50% Right Brained

Raul Soto's Estimated Salary Range

About Raul Soto's Current Company

Johnson & Johnson Vision

Frequently Asked Questions about Raul Soto

What company does Raul Soto work for?

Raul Soto works for Johnson & Johnson Vision


What is Raul Soto's role at Johnson & Johnson Vision?

Raul Soto is Senior Principal Software Engineer


What is Raul Soto's personal email address?

Raul Soto's personal email address is r****[email protected]


What is Raul Soto's business email address?

Raul Soto's business email addresses are not available


What is Raul Soto's Phone Number?

Raul Soto's phone (305) ***-*247


What industry does Raul Soto work in?

Raul Soto works in the Medical Devices industry.


About Raul Soto

📖 Summary

Senior Principal Software Engineer @ Johnson & Johnson Vision Jacksonville, Florida AreaOperations/ Quality Systems and Validation Engineering Manager @ KellyOCG Operations Manager at ASP From December 2012 to March 2013 (4 months) Principal Software Quality Engineer at Johnson & Johnson Vision Care @ Johnson & Johnson • Lead Software Quality Engineering (SQE) function in the site, support multiple global/local Computerized Systems Validation (CSV) projects for manufacturing automated systems, IT applications, and computerized analytical laboratory instruments. Includes the validation and deployment of new computerized systems; upgrade, change control, continuous improvement of existing ones.• Leadership: Establish strategic vision for group; current/upcoming projects, deliverables, priorities, bandwidth. Establish/strenghten relationships between SQE group, internal customers. Developed SQE role matrix of core competencies. • Technical Stewardship of CSV Process: CSV SME. Responsible for ensuring GxP computerized systems are in compliance, validated, defensible; ensuring procedures, templates, processes are aligned with current requirements from J&J, US/international regulatory agencies. Lead risk assessment/FMEA exercises, root cause analysis, corrective action implementation, Gap analysis and corrective actions. Defend validated computerized systems in external (FDA, BSI, etc.) and internal (JJRC, etc) audits and reviews.• Mediator and “Firefighter”: Going into trenches, resolving problems; successfully leading CSV groups through emergencies in high-stress settings, maintaining facts-oriented approach, persevering with integrity. Successfully keeping multiple projects on track• Accomplishments: o Leading CSV Remediation for 33 automated manufacturing lines, HMI/SCADA, machine vision systemso Led validation of multiple major SAP international expansions (Asia, Europe, S.America).o Led validation of updated Manufacturing Execution System (MES) . Project won Siemens 2015 Camstar Manufacturing Star Awardo Led CSV aspect of Microbiology Lab remediation, met very aggressive timeline within budgeto Part of team that developed global CSV procedures, templates for IT apps, Lab systemso Prepared/taught Certified Quality Engineering (CQE) statistics course From April 2013 to April 2018 (5 years 1 month) Jacksonville, Florida AreaStaff Software Quality Engineer @ Advanced Sterilization Products • Managed operations and professional exempt personnel for the Kelly Outsourcing and Consulting Group at ASP.• Subject matter expert for software quality, testing, and validation.• Review and approval of software validation deliverables, including specific work products, project plans and configuration management, compliance assessments, validation plan and report, user / functional requirements, design / configuration / technical specifications, traceability matrix, risk assessments, IQ/OQ/PQ testing, SOPs.• Supported validation and change control of GXP computerized systems in multiple functional departments: Operations, Quality, IT, R&D.• Ensure project team members have appropriate training to perform their respective CSV (Computer System validation) project functions. Support audits; instruct, monitor and work with development partner vendors and suppliers to meet ASP’s CSV expectations. From December 2012 to March 2013 (4 months) Irvine, CASenior QA Analyst (consultant) @ InnovoCommerce LLC Lead the creation of validation documents and protocols, and the execution of validation testing, for a new Clinical Trials Management software application:Validation Plan, Product Requirements, Functional and Technical Design Requirements, IQ, OQs, Validation Summary Report. From October 2012 to December 2012 (3 months) Irvine, CATest Manager (IS Corporate) @ Amgen • Led teams of onsite and off-shore testers performing development, testing, and validation of local and global computerized system. CSV subject matter expert.• Led the successful validation of multiple enterprise-level computer systems, with excellent client feedback. Some examples: Maximo, BlueCielo (engineering drawings management), IReview/JReview (clinical data review), Documentum (regulated documents management), SumTotal (learning management), Cognos / Informatica / Business Objects (business intelligence), SAP (enterprise resource management).• Led the successful qualification of major components of Amgen’s IT infrastructure, meeting a very tight schedule, and with excellent client feedback. Some examples: File Access Control, Host Access Control, LDAP, Active Directory, HPSA, PKI, Siteminder. From June 2006 to September 2012 (6 years 4 months) Thousand Oaks, CAComputer Validation Team Leader @ AstraZeneca Pharmaceuticals • Led a team of professionals (engineers, chemists, pharmacists, computer scientists) and contractors supporting three (3) sites; responsible for multiple validation projects in the following areas: Packaging Automation; Laboratories (Stability, Microbiology, Raw Materials, Finished Goods, Analytical Development labs); Information Technology & Services (IS/IT applications, services and infrastructure); and Warehouse Information Systems. • Prepared and monitored revenue budget and capital expenses. Strong emphasis on professional development of internal resources, cross-training, and engagement with clients.• Successfully led several major projects, delivered on time and within budget: High-Speed Tablet Packaging Lines & Packaging Building Startup; multi-site SAP R/3 Validation; validation of the IT network and all IT infrastructure for 3 manufacturing sites; Labs 21CFR Part 11 upgrades.• Developed and maintained computer validation SOPs. Reviewed and approved Computer Validation master plans, protocols (IQ, OQ, PQ) and reports, user requirement and functional specifications, software/equipment acceptance tests, software and hardware design specifications, all other related documentation. Supported computer systems validation audits: internal, FDA, international bodies. • Expertise with Rockwell (Allen Bradley) PLCs, RSView32 SCADA system, machine vision systems. From September 2001 to June 2006 (4 years 10 months) Process Engineer / Systems Interaction Engineer @ Hewlett-Packard Patents / Inventions :1. Two-sided transaction photo inkjet printer mechanism, HP Invention Disclosure # 10017095 2. Modular service station for horizontal printing mechanism. HP Invention Disclosure # 10019219 3. Consolidated service station for horizontal printing mechanism. HP Invention Disclosure # 10019213 • SIE : Developed and implemented corrective actions for technical, quality, and performance issues caused by interactions among writing system components. Developed writing systems testing for new printer introductions in HP R&D San Diego.• Increased line yield by approximately 15% through the development of a Monte Carlo-based statistical system to determine mechanical tolerances for multi-cartridge printers.• Process Engineering: Developed, qualified, and implemented process improvements for automated production lines. Established preventive and predictive maintenance procedures. • Reduced scrap by approximately 50% in the Adhesive and Encapsulant dispenser machines by optimizing their operational parameters, using Design of Experiments and SPC. • Expertise with Omron PLCs, pneumatics, machine vision systems. From 1996 to 2001 (5 years) Aguadilla PRTechnical Services Engineer @ Johnson & Johnson • Transferred and validated new product introductions in the Cardiovascular, ObGyn, and Ophtalmic product lines, and other wound closure medical devices. Performed feasibility studies, IQs /OQs /PQs. • Improved processes using tools such as SPC, DOE, ANOVA, hypothesis testing, process capability analysis. Developed statistical sampling plans for validations and regular production processes. • Expertise with TI PLCs, Adept robots, Multivac and Uhlmann packaging machines. From 1993 to 1996 (3 years) San Lorenzo, PR


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In a nutshell

Raul Soto's Personality Type

Extraversion (E), Intuition (N), Feeling (F), Judging (J)

Average Tenure

3 year(s), 1 month(s)

Raul Soto's Willingness to Change Jobs

Unlikely

Likely

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