IT / OT Validation Lead

hace 2 meses

Bogotá, Colombia Medtronic A tiempo completo

At Medtronic, you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

This position is needed to lead the work with our partners in OI Quality Team to address the following key challenges:

  1. Define “One Best Way” IT testing processes to support team:
    - Define boundary between IT “Business Process” vs. “QMS”
    - Define roles & responsibilities between Global IT, Global Mfg., GOSC Quality, Ops Innovation & CQS
    - Standardize the use of processes by varying OI project teams, avoiding compliance vulnerabilities
    - Work with IT audit team to ensure MSCM is followed when applicable and help OI leverage best practices
  2. Work with cross-functional resources:
    - Global IT Quality/Compliance
    - Software Validation/QA support on site deployment teams
  3. Define and standardize the use of global tools:
    - PLM
    - QMS entities
    - Drive enhancements in the use of tools and alignment with regulatory requirements

The role of the IT/OT Validation Lead for GOSC IT – Operations Innovation is to lead validation services required for the successful delivery of IT / OT projects. This role requires strong knowledge in Regulatory requirements for Application testing for ISO13485, CFR 21 Part 11 and SOX (if applicable). This position is for a Principal Engineering Professional who is willing to work in a global environment with multiple functional areas like: IT, Ops & Innovation, QA, and Mfg. SMEs.

This position will report to the IT Platform Manager for Digital Shop Floor / Ops & Innovation located in Costa Rica. The chosen candidate will have the opportunity to contribute to global programs within the IT Ops & Innovation Portfolio, providing a great opportunity to learn and develop new skills.

IT/OT Validation Activities

  • Leads validation IT/OT validation activities as assigned
  • Provide validation & technical support through the preparation, execution, data analysis, & report writing for IV, OV & PV protocols
  • Ownership of Change Requests (CRs) related to project validation responsibilities
  • Perform compliance & technical reviews/approvals of protocols & protocol data
  • Author project quality masterplans (PQMPs), validation plans (VPLs), & other key validation documentation
  • Author & execute assigned IV, OV & PV protocols for direct impact systems/processes per approved timeframes, requiring no guidance & direction
  • Ensure compliance of validation protocols executed are aligned with local, corporate & regulatory regulations
  • Lead validation failure investigations & non-conformities utilizing root cause analysis techniques
  • Create & modify existing validation procedures & configuration item lists (CILs) as required
  • Write/Review specifications, procedures, & other required supporting documents to maintain the validated state of equipment & processes
  • Participate in FAT, SAT commissioning efforts for equipment, automation systems & processes & successfully transition into the ownership role for validation efforts related to the equipment
  • Identify process improvements before equipment, systems or processes are placed under change control during validation
  • Budget oversight as needed
  • Contractor scheduling & oversight as needed
  • Other accountabilities, as assigned

Required Knowledge and Experience:

  • Bachelor’s degree in engineering, Computer Science, or applicable technical degree or proven equivalent relevant work experience required
  • Master's Degree preferred
  • Minimum of seven (7) years validation or quality related discipline experience in either life science, med tech or pharmaceutical environment required
  • Experienced with regulatory requirements & industry standards for pharmaceutical &/or medical device manufacture, such as 21 CFR Part 11, GAMP5, ISO, electronic records retention, configuration items list, FDA & ICH guidance documents required
  • Demonstrated experience using root-cause analysis techniques to solve problems preferred
  • Ability to read, write & understand complicated product documentation preferred
  • Demonstrated leadership & project management skills: two-way communication skills with customers, internal/external, project team & management; interpersonal & team building skills; achievement of project timelines & customer requirements preferred
  • Ability to write technical documentation based on equipment manuals preferred
  • Experience in med-tech/pharmaceutical manufacturing preferred. Knowledgeable in GMP concepts preferred
  • Knowledge of standard operating procedures with attention to high-level concepts preferred
  • Knowledge of QMS systems and best practice approaches
  • Ability to manage multiple tasks/deadlines & prioritize properly based on process needs preferred

Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people. We are engineers at heart—putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here.

#J-18808-Ljbffr

  • IT / Ot Validation Lead

    hace 3 meses

    Bogotá, Cundinamarca, Colombia Medtronic A tiempo completo

    At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life This position is needed to lead the work with our partners in OI Quality Team to address the...

  • IT Validation Lead

    hace 2 meses

    Bogotá, Bogotá D.E., Colombia Medtronic A tiempo completo

    About the RoleAt Medtronic, we're committed to alleviating pain, restoring health, and extending life. As an IT/OT Validation Lead, you'll play a critical role in leading our team's efforts to validate IT and OT systems, ensuring they meet regulatory requirements and are aligned with our company's mission.Key Responsibilities• Lead validation activities...

  • IT Validation Specialist for GxP Systems

    hace 4 semanas

    Bogotá, Bogotá D.E., Colombia ConvaTec A tiempo completo

    About ConvaTecWe are a global medical products and technologies company, focused on solutions for the management of chronic conditions. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs.Job DescriptionThe CSV Analyst will play an integral role in ensuring...

  • Computer Systems Validation Specialist

    hace 1 mes

    Bogotá, Bogotá D.E., Colombia ConvaTec A tiempo completo

    About the Role:The CSV Analyst will play an integral role in ensuring that IT managed GxP computerized systems and infrastructure are validated or qualified in accordance with corporate quality standards.Duties and Responsibilities:The CSV Analyst will oversee GxP impacting projects to ensure that all applicable regulatory and compliance requirements are met...

  • Computer Systems Validation

    hace 7 meses

    Bogotá, Colombia ConvaTec A tiempo completo

    Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we provide our products and services...

  • Software Validation Project Lead Latin America

    hace 4 semanas

    Bogotá, Bogotá D.E., Colombia Boston Scientific A tiempo completo

    About Boston ScientificAs a global leader in medical science for over 40 years, we are committed to addressing the most pressing challenges with a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient outcomes, create value for our customers, and support our...

  • IT Network Security Specialist

    hace 1 mes

    Bogotá, Bogotá D.E., Colombia Emapta A tiempo completo

    Transform the Future of EnergyImagine playing a vital role in shaping the renewable energy landscape. As a Network Administrator at Emapta Latam, you'll join a pioneering organization that's driving sustainable energy solutions across the United States.Your Key Responsibilities:Ensure technical security compliance for IT/OT environmentsMonitor network logs...

  • Especialista en Ventas Previas

    hace 2 meses

    Bogotá, Bogotá D.E., Colombia Sonda It A tiempo completo

    **¿Por qué trabajar en SONDA?**En SONDA, buscas una carrera que te permita crecer y desarrollarte como profesional. Nuestro equipo de ventas previas busca a alguien con pasión y dedicación a la innovación y la tecnología.**Funciones del puesto:**Desarrollar propuestas técnicas en conjunto con equipos multidisciplinarios.Colaborar en el relacionamiento...

  • Strategic IT Project Lead

    hace 4 semanas

    Bogotá, Bogotá D.E., Colombia Patagonian A tiempo completo

    Are you looking for a new challenge? Patagonian is seeking an experienced Strategic IT Project Lead to join our team!Job SummaryWe are searching for a skilled and results-driven project manager to lead the coordination of IT-related projects. The ideal candidate will have at least 3 years of experience in project management, with a strong background in...

  • IT Project Lead

    hace 2 semanas

    Bogotá, Bogotá D.E., Colombia Patagonian A tiempo completo

    At Patagonian, we are seeking a highly skilled IT Project Lead to oversee the coordination of our IT related projects. With a minimum of 3 years of experience in this field, you will be responsible for managing client expectations, developing detailed work plans, and leading projects from requirements definitions through deployment.About the RoleWe are...

  • Global IT Project Lead

    hace 4 semanas

    Bogotá, Bogotá D.E., Colombia Convatec A tiempo completo

    About UsConvatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions.Job DescriptionWe are seeking an experienced Project Manager to lead our global IT/Technology projects. The successful candidate will play a pivotal role in the execution of projects within budget and on...

  • IT Security Team Lead and Analyst

    hace 4 semanas

    Bogotá, Bogotá D.E., Colombia Scotiabank A tiempo completo

    Job OverviewWe are looking for a skilled professional to join our team as an IT Security Team Lead and Analyst. This role is responsible for championing a customer-focused culture and leading a team to investigate, escalate, and track control deficiencies.

  • IT Security Assurance Lead

    hace 4 semanas

    Bogotá, Bogotá D.E., Colombia Scotiabank A tiempo completo

    About the RoleWe are committed to investing in our employees and helping you continue your career at ScotiaBank. This is an excellent opportunity for a skilled IT security professional to join our team as a Senior Cybersecurity Manager.The successful candidate will lead a team of 4 analysts, reviewing privileged accesses and configurations on a scheduled...

  • Especialista en Ventas de Soluciones de Tecnología

    hace 3 semanas

    Bogotá, Bogotá D.E., Colombia Sonda It A tiempo completo

    ¿Por qué ser parte de SONDA?Nosotros amamos lo que hacemos y tenemos pasión por la innovación. Estamos convencidos de que a través del conocimiento y de la tecnología vamos a transformar los negocios de nuestros clientes y el futuro.En SONDA vivirás una experiencia de trabajo con diversas oportunidades de desarrollo personal y profesional.Un excelente...

  • Data Team Lead

    hace 2 meses

    Bogotá, Cundinamarca, Colombia World Business Lenders, LLC A tiempo completo

    World Business Lenders (WBL) provides general purpose short-term real estate collateralized commercial loans to a broad customer base comprised of small and medium sized businesses throughout the United States that lack access to traditional funding. WBL is a U.S.based company with a 100% remote workforce. This is a remote Contract/Consultant position....

  • OT Consultants

    hace 3 meses

    Bogotá - Remoto, Colombia GSB A tiempo completo

    Main Activities / Responsibilities: ● Systems Architecture: Ensures that the stakeholder security requirements necessary to protect the organization’s mission and business processes are adequately addressed in all aspects of enterprise architecture including reference models, segment and solution architectures, and the resulting systems supporting those...

  • IT Project Management Lead

    hace 2 meses

    Bogotá, Bogotá D.E., Colombia Medtronic A tiempo completo

    Transforming Healthcare through Strategic Project ManagementWe're a pioneering medical technology company dedicated to making a meaningful impact on global healthcare. As a key member of our team, you'll play a vital role in driving innovative solutions that improve patient care and outcomes.About the RoleAs a Principal IT Project Management Lead, you'll be...

  • Platinion Lead IT Architect

    hace 3 meses

    Bogotá, Cundinamarca, Colombia Boston Consulting Group A tiempo completo

    **Locations**: Colombia | Chile Who We Are Boston Consulting Group partners with leaders in business and society to tackle their most important challenges and capture their greatest opportunities. BCG was the pioneer in business strategy when it was founded in 1963. Today, we help clients with total transformation-inspiring complex change, enabling...

  • IVVQM (Integration, Verification, Validation and Qualification Manager)

    hace 5 meses

    Bogotá, Colombia Thales A tiempo completo

    Thales people architect identity management and data protection solutions at the heart of digital security. Business and governments rely on us to bring trust to the billons of digital interactions they have with people. Our technologies and services help banks exchange funds, people cross borders, energy become smarter and much more. More than 30,000...

  • Technical IT Lead for AAA Game Development

    hace 1 hora

    Bogotá, Bogotá D.E., Colombia Electronic Arts A tiempo completo

    Lead Desktop Support EngineerWe are seeking a highly skilled Technical IT Lead to join our team in Bogota, Colombia.About UsElectronic Arts is a global team of creators, storytellers, technologists, and innovators. We believe amazing games and experiences start with diverse teams that serve players and communities worldwide.Job DescriptionThis role will be...