Ingeniero de Validaciones at Vontive

Jiutepec, Morelos, Mexico

Vontive Logo
Not SpecifiedCompensation
Mid-level (3 to 4 years)Experience Level
Full TimeJob Type
UnknownVisa
Healthcare, Medical Devices, Kidney CareIndustries

Requirements

  • Ingeniería Química, Químico Industrial, Ingeniería Farmacéutica o Licenciatura en Farmacia
  • 1 año de experiencia en validaciones, calificación de equipos de manufactura y sistemas críticos, y validación de procesos
  • Conocimiento en la regulación relacionada con la Industria Farmacéutica
  • Inglés intermedio – avanzado
  • Conocimiento de la Regulación Sanitaria local (COFEPRIS), NOM-241, NOM-059, normas GAMP, CFR 21 parte 11, estándares internacionales, ISO 9001 y requisitos corporativos

Responsibilities

  • Elaboración, coordinación, ejecución y revisión de protocolos de Validación y Calificación para cumplir con políticas internas de Vantive y normas nacionales e internacionales
  • Fortalecer el mejoramiento continuo en procesos de manufactura y producción de servicios críticos de planta
  • Vigilar cumplimiento de requisitos regulatorios locales (COFEPRIS), NOM-241, de países de exportación, estándares internacionales, ISO 9001, requisitos corporativos y administración de riesgos
  • Asegurar cumplimiento de NOM-059 para sistemas computacionales, normas GAMP, CFR 21 parte 11 y estándares de validación de sistemas computacionales
  • Mantener el estatus de validación conforme a la normatividad aplicable
  • Realizar calificación de equipos, sistemas críticos y software en procesos de la compañía
  • Elaborar protocolos de limpiezas y ejecutar validación de procesos
  • Cumplir con los Planes Maestros de Validación vigentes
  • Generar documentación requerida para calificaciones o validaciones asignadas
  • Elaborar protocolos y reportes de calificación y validación asignados
  • Elaborar y mantener actualizados procedimientos de calificación y validación según estándares corporativos y legislación nacional e internacional
  • Preparar, seguir y atender auditorías internas y externas, asegurando Buenas Prácticas de Fabricación
  • Proporcionar información y soporte para la Verificación Continua del Proceso

Skills

Key technologies and capabilities for this role

ValidaciónProtocolos de ValidaciónElaboración de ProtocolosCoordinaciónEjecuciónRevisión

Questions & Answers

Common questions about this position

What is the employment type for this position?

This is a full-time position.

Is this role remote or does it require on-site work?

This information is not specified in the job description.

What are the main responsibilities of the Ingeniero de Validaciones role?

The role involves creating, coordinating, executing, and reviewing validation and qualification protocols to comply with internal policies and national/international regulations, monitoring regulatory compliance including COFEPRIS and ISO 9001, ensuring compliance with NOM 059 and GAMP for computer systems, and qualifying equipment, critical systems, and software.

What is the company culture like at Vantive?

Vantive fosters a community of focused, courageous people who don't settle for mediocrity, are driven to improve patients' lives worldwide, and create an environment where employees are happy, successful, and inspire each other, with a strong sense of purpose across the organization.

What makes a strong candidate for this validation engineer position?

Strong candidates will have expertise in validation protocols, regulatory compliance with standards like COFEPRIS, NOM-241, ISO 9001, NOM 059, GAMP, and CFR 21 Part 11, and experience in qualifying equipment, critical systems, software, and cleaning protocols for 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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