Validation Engineer - 1 at Vontive

Tijuana, Baja California, Mexico

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, Healthcare, Kidney CareIndustries

Requirements

Knowledge of FDA regulations for export countries, international standards (ISO 9001/ISO 13485), and corporate requirements, with special attention to 21CFR 820.22, 30, 65, 70, 75, 90, 100, 130, 184, and 198
Skills in statistical analysis of process variation, process/product control, and risk analysis for product families
Expertise in GAMP 5, Annex 11 EC, CFR 21 Part 11, and international standards for computer system validation and data integrity
Ability to qualify and operate controlled areas within applicable environmental specifications
Participation in regulatory decision-making structures for compliance and quality standards
Direct support in regulatory inspections
Ownership in quality system compliance through investigations, ensuring NCR/CAPA follow-up activities are executed, completed, and documented correctly (and as approver, ensuring adequate root cause investigation and proper closure/execution)

Responsibilities

Execute and verify maintenance of the site's validated state, ensuring equipment functions efficiently and correctly to produce quality products
Elaborate, coordinate, and execute validation and qualification protocols to comply with internal policies, international standards, and support continuous improvement in manufacturing processes and critical plant services
Ensure compliance with applicable regulations to maintain validation status
Perform qualification and validation process activities
Qualify critical equipment and systems used in manufacturing processes
Comply with the current Master Validation Plan
Review validation protocols and reports
Collect information annexed to validation protocols
Elaborate and keep updated procedures applicable to qualification and validation processes according to corporate standards and national/international legislation
Ensure qualification and operation of controlled areas within applicable environmental specifications
Participate in regulatory compliance and quality standards decision-making for all described operations
Provide direct support in regulatory inspections
Support quality system compliance through participation in investigations as owner, ensuring NCR/CAPA activities are executed, completed, and documented correctly
As quality approver (if applicable), ensure investigations have adequate root cause analysis and that closures/actions are executed correctly, meet system requirements, and are properly documented

Skills

Validation Protocols

Equipment Qualification

FDA Regulations

21CFR 820

ISO 9001

ISO 13485

Statistical Process Analysis

Process Control

Risk Analysis

Quality Engineering

Manufacturing Processes

Vontive

Provides investment property mortgage solutions

About Vontive

Vontive provides investment property mortgages using technology to simplify and speed up the loan process. Their main product is a "bolt-on" technology that allows retail brands to easily launch their own mortgage services without needing programming skills. This no-code solution can be set up in just a few weeks, making it quicker for brands to offer mortgages. Vontive stands out from competitors by acting as a bridge between real estate investors, lenders, and capital providers, charging fees for their services that reduce traditional risks and inefficiencies in real estate financing. The company's goal is to modernize the investment real estate market by making the mortgage process more efficient and transparent for both retail brands and financial institutions.

San Francisco, CaliforniaHeadquarters

2017Year Founded

$32.1MTotal Funding

DEBTCompany Stage

Financial Services, Real EstateIndustries

11-50Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Unlimited Paid Time Off

Parental Leave

Short- and Long-term Disability Coverage

Life Insurance

Wellness Program

Risks

Increased competition from fintech companies could erode Vontive's market share.

Potential regulatory scrutiny may lead to higher compliance costs and challenges.

Economic downturns could impact demand for investment property mortgages.

Differentiation

Vontive offers a no-code, white-label mortgage solution for real estate investors.

The platform integrates financial institutions through a unique debt marketplace.

Founded by industry veterans, Vontive leverages decades of mortgage and financial expertise.

Upsides

Vontive ranked #10 on the 2022 Deloitte Technology Fast 500 with 9,154% growth.

The company has financed over $1.1 billion in residential properties since April 2022.

Vontive's B2C ecosystem reaches over 1.5 million real estate investors.

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