LinkedInJesus A. Gonzalez
Jesus A. Gonzalez

Jesus A. Gonzalez

Manufacturing Engineering Consultant

Location
Miami, Florida
Industry
Medical Devices
Current
  1. BioTeknica
Previous
  1. OceanTrust Mortgage Corp.,
  2. BAXTER DIAGNOSTICS, INCORPORATED. Miami, Florida.,
  3. DADE DIAGNOSTICS, INC. Miami, Florida.
Education
  1. US Coast Guard
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BioTeknica

BioTeknica

Engineering Consultant

– Present

View full profile

Background

Summary

Business Consultant with extensive experience in healthcare and financial industries. Strong focus to drive growth and profitability with emphases in product marketing, business operations, and systems integration. Diverse operational experience in management, packaging, strategic business planning, quality assurance, information systems, and sales.

STRENGTHS

• Entrepreneurial leader • Creative problem solver • Strong negotiator
• Stakeholder collaboration • Statistical analysis • Innovator

Experience

Engineering Consultant

BioTeknica
– Present (3 years 2 months)Coral Gables, Fl

BIOTEKNICA, Miami Florida (September. 2011 to Present)
Manufacturing/Validation Engineering Consultant – Pharmaceutical and Consumer Health Care – Miami Lakes, and Davie, Fl.
Project manager, servicing manufacturing; supporting Transdemal liquid coating, product patch, pouch forming, filling, and sealing machinery.
• Developed and executed Installation Qualifications (IQs), Operational Qualifications (OQs), Performance Qualifications (PQs), Process Validations (PVs), Cleaning (CV), and Decommissioning machinery.
• Rewrite SOP’s for setup/operation and cleaning of Encapsulators, Comminuting and Tri-blender machinery
Packaging Engineering Consultant - Medical/Surgical Corporation – Dover, Ohio
Engineering site lead for validation remediation of product packaging. Implement remediation strategies that would effectively revalidate sterile barrier packages, and non-sterile capital equipment packages. Update package design validation protocol and validation report SOP’s to provide a robust testing plan that synchronizes with ASTM standards.
• Author of thirty three (33) Package Design test protocols, fifty (50) Package Design test reports, twenty six (26) Shelf Life real time aging study protocols, and ten (10) Shelf life reports.
• Providing expertise in packaging redesign and new product development training to Manufacturing and QA personnel..
• Resolve CAPA packaging related issues.
• Evaluate and selected packaging materials and suppliers.
• Project lead for product transfer from accompanying facilities; responsibilities include master plan for packaging validation, and quality system alignment.

Founder and former President

OceanTrust Mortgage Corp.
(19 years)

A Correspondent Mortgage Lender Headquarters Miami, Fl.,
Residential and Commercial Lending
Created from start-up, developed and implemented business strategies that expanded OceanTrust Mortgage operations from corporate, and branch offices in Florida to offices and loan processing centers in Texas, Maryland, Virginia and Israel.
Generated over $470M in sales for the business by 2009.
Production growth in sales volume climbed from 40M in 2004 to 87.5M in 2007.
Automated training tools, templates and processes to optimize performance of the administrative staff, employees, and over 30 loan officers nationally.
Diversified marketing strategies to overcome tightened underwriting guidelines, and the decreasing buyer pool.
Negotiated over 80 partnerships/distribution channels with top fortune 500 financial institutions.
Bundling and outsourcing to minimizing corporate expenditures by over 50%.

Document Systems Manager - Quality Assurance Group

BAXTER DIAGNOSTICS, INCORPORATED. Miami, Florida.
(2 years)

Accountable for managing the Manufacturing Information Database Systems Group insuring total compliance with good manufacturing processes. Assuring the integrity, readability, coherence, usability, traceability, and security of the data.
Chaired cross-functional team meetings to approve the implementation of new, and re-engineered product/system specifications.
Represented QA in FDA, and other governmental audits of over 45 products.
Consolidated the Product configuration/Device records groups to streamline information accessibility, eliminate redundancies, and reduce personnel; delivering solid verifiable savings of $520K/yr.
Responsible for the departments operating budget of approximately $600k, strategic planning, and leadership of a staff consisting of engineers, technicians, analysts and clerical personnel.

Senior Packaging/Manufacturing Engineer – Mfg. Engineering Department

DADE DIAGNOSTICS, INC. Miami, Florida.
(9 years)

Developed, and re-engineered manufacturing processes to insure optimization of work-flow, in Baxter’s Miami, and Puerto Rico organizations. Multiple project coordination of product life-cycle process, from R&D conception, to end product distribution.
Developed, manufacturing processes, shipping and warehousing methods to insure optimization of product/work-flow.
Coordinated and supervised the build-out of Baxter’s manufacturing facilities; budgeting time and costs. Selected general contractors and trade contractors to complete specific parts of the project. The timely implementation of this system in our P.R. facilities resulted in a cost savings of 1.5M/month,
Received Corporate Executive recognition for supporting key customers within North America region. Revamp of product requirements, influenced the discontinuation of a new product in R&D stage, making sound design recommendations.
Troubleshooting systems, establishing materials environmental acceleration testing procedures, facilities planning, clean room design (class100), design utilities, manpower planning, short and long-range process design, capacity analysis and establishing production methods per GMP standards. Vendor selection and validation.
Re-engineered production processes introducing cost reduction strategies.
Instrument and component packaging/labeling creation for medical products. Develop specifications, engineering drawings, vendors selection and validation for over 50 product lines.

Languages

  1. Spanish

Skills

  • Personal Finance
  • Process Improvement
  • Cross-functional Team...
  • Leadership
  • Product Management
  • Business Development
  • Start-ups
  • Strategic Planning
  • Budgets
  • Management
  • Quality Assurance
  • Business Strategy
  • Product Development
  • Sales
  • Manufacturing
  • Credit
  • Customer Service
  • See 2+  See less

Education

US Coast Guard

USCG Captains and Masters License, Captains and 50 ton Masters

Florida International University

Professional Certificate, Production and Manufacturing

Honors & Awards

Awarded Second Place Chicago, Ill. Society of Packaging and Handling Engineers
“Innovative design using new technologies in high barrier plastics for use in moisture sensitive products.”

Honorable Mention in a new product-packaging exhibition. New York City, N.Y. Published article in Journal of Packaging Digest, titled “A Clear Move towards Savings”

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