Vantive
Overview
Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. We are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients — that is what Vantive aspires to deliver. We aim to offer meaningful work and a community of focused, courageous people who strive to improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities. Your Role
We are seeking a seasoned Technical Lead to serve as the IT system owner and principal technical authority for TrackWise (Sparta Systems/Honeywell) and adjacent Quality/Regulatory applications. The role is responsible for ensuring Quality and Regulatory global applications meet business requirements and remain in a validated state throughout their lifecycle. This is a high-visibility, hands-on leadership role responsible for the stability, configuration, integration, and lifecycle management of the enterprise QMS platform at Vantive. The ideal candidate brings deep TrackWise configuration experience coupled with modern full-stack engineering skills to drive reliability, scalability, and compliant change. What You'll Be Doing
Product & System Ownership Serve as IT system owner for TrackWise, accountable for end-to-end technical health, roadmap, and lifecycle. Own incident/problem/change processes (ITIL) and SLAs; lead major incident triage and root-cause analysis. Coordinate with vendor (Sparta Systems/Honeywell) for patches, upgrades, and support cases; manage risk and release notes impact assessments. Configuration & Platform Engineering Design, configure, and extend TrackWise workflows, forms, business rules, records, and security/roles. Engineer robust integrations with ERP/MES/PLM/Labeling and other QA/RA systems (e.g., complaints, CAPA, audits) using Java/.NET and SQL Server; leverage scripting/automation where applicable. Leverage AWS for hosting patterns, automation, and resiliency (e.g., EC2, S3, RDS/SQL Server on AWS, IAM, CloudWatch). Validation, Compliance & Audit Readiness Operate within GxP and 21 CFR Part 11 requirements: lead Computer System Validation (CSV) deliverables. Maintain validation plans, IQ/OQ/PQ scripts, traceability matrices, risk assessments, and change controls. Support internal/external audits; ensure procedures, SOPs, and records are current and inspection ready. Stakeholder Management & Leadership Engage business SMEs across Quality and Regulatory to capture requirements and translate to scalable technical solutions. Communicate status, risks, and decisions effectively to leadership; influence cross-functional priorities. What You'll Bring
Bachelor's degree in computer science, Information Systems, Engineering, or related field; Master's a plus. 7-10+ years of total IT experience with increasing responsibility in enterprise applications and integrations. Demonstrated success leading technical delivery in highly regulated industries (medical device, pharma, biotech). 3-5+ years of hands-on TrackWise configuration and administration (workflows, forms, rules, security, records, reporting). 2-3+ years of modern full-stack engineering with one or more: Java or .NET; strong SQL (Microsoft SQL Server); scripting (PowerShell). Experience with Docker containers and AWS services for hosting, automation, monitoring, and resilience. Proven delivery in validated (GxP) environments with 21 CFR Part 11 controls: strong change control and SDLC discipline. Solid understanding of performance engineering, observability, and incident/problem management (ITIL). Excellent communication, stakeholder management, and technical leadership; ability to mentor and set engineering standards. Technical Stack TrackWise (Sparta Systems/Honeywell). Java or .NET (C#), REST/SOAP services, JSON/XML. Microsoft SQL Server (T-SQL), performance tuning, stored procedures. AWS (e.g., EC2, S3, IAM, CloudWatch) and on-prem connectivity patterns. Docker; scripting/automation with PowerShell; optional Node.js or front-end technologies for UI extensions. Source control and CI/CD (e.g., Git, Azure DevOps/GitHub Actions); environment promotion under CSV constraints. Preferred Skills TrackWise upgrade/migration experience (major version changes, remediation planning, vendor coordination). Hands-on with event-driven architectures, message queues, or integration platforms (e.g., MuleSoft, Boomi). Exposure to other QA/RA systems (e.g., Veeva QMS/RA, Labeling, PLM) and data exchange patterns. Experience with ServiceNow/ITSM, Agile methods (Scrum/Kanban), and regulated SDLC toolchains. Security-by-design mindset (identity/role design, audit trails, segregation of duties). US Benefits at Vantive This is where your well-being matters. Vantive offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical, dental and vision coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Aon Pooled Employer Plan ("Aon PEP"), and Vantive's 401(k) retirement savings plan with a robust set of investment options, education, and resources. Flexible Spending Accounts, educational assistance programs, paid holidays, paid time off (20–35 days based on length of service), family and medical leaves, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Equal Employment Opportunity Vantive is an equal opportunity employer. Vantive evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Knowledge of rights: Workplace Discrimination is Illegal. Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If you need a reasonable accommodation for any part of the application or interview process, please indicate your request and contact information in the form. Recruitment Fraud Notice Vantive has discovered incidents of employment scams where fraudulent parties pose as Vantive employees, recruiters, or other agents. To learn how you can protect yourself, review our Recruitment Fraud Notice.
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Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. We are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients — that is what Vantive aspires to deliver. We aim to offer meaningful work and a community of focused, courageous people who strive to improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities. Your Role
We are seeking a seasoned Technical Lead to serve as the IT system owner and principal technical authority for TrackWise (Sparta Systems/Honeywell) and adjacent Quality/Regulatory applications. The role is responsible for ensuring Quality and Regulatory global applications meet business requirements and remain in a validated state throughout their lifecycle. This is a high-visibility, hands-on leadership role responsible for the stability, configuration, integration, and lifecycle management of the enterprise QMS platform at Vantive. The ideal candidate brings deep TrackWise configuration experience coupled with modern full-stack engineering skills to drive reliability, scalability, and compliant change. What You'll Be Doing
Product & System Ownership Serve as IT system owner for TrackWise, accountable for end-to-end technical health, roadmap, and lifecycle. Own incident/problem/change processes (ITIL) and SLAs; lead major incident triage and root-cause analysis. Coordinate with vendor (Sparta Systems/Honeywell) for patches, upgrades, and support cases; manage risk and release notes impact assessments. Configuration & Platform Engineering Design, configure, and extend TrackWise workflows, forms, business rules, records, and security/roles. Engineer robust integrations with ERP/MES/PLM/Labeling and other QA/RA systems (e.g., complaints, CAPA, audits) using Java/.NET and SQL Server; leverage scripting/automation where applicable. Leverage AWS for hosting patterns, automation, and resiliency (e.g., EC2, S3, RDS/SQL Server on AWS, IAM, CloudWatch). Validation, Compliance & Audit Readiness Operate within GxP and 21 CFR Part 11 requirements: lead Computer System Validation (CSV) deliverables. Maintain validation plans, IQ/OQ/PQ scripts, traceability matrices, risk assessments, and change controls. Support internal/external audits; ensure procedures, SOPs, and records are current and inspection ready. Stakeholder Management & Leadership Engage business SMEs across Quality and Regulatory to capture requirements and translate to scalable technical solutions. Communicate status, risks, and decisions effectively to leadership; influence cross-functional priorities. What You'll Bring
Bachelor's degree in computer science, Information Systems, Engineering, or related field; Master's a plus. 7-10+ years of total IT experience with increasing responsibility in enterprise applications and integrations. Demonstrated success leading technical delivery in highly regulated industries (medical device, pharma, biotech). 3-5+ years of hands-on TrackWise configuration and administration (workflows, forms, rules, security, records, reporting). 2-3+ years of modern full-stack engineering with one or more: Java or .NET; strong SQL (Microsoft SQL Server); scripting (PowerShell). Experience with Docker containers and AWS services for hosting, automation, monitoring, and resilience. Proven delivery in validated (GxP) environments with 21 CFR Part 11 controls: strong change control and SDLC discipline. Solid understanding of performance engineering, observability, and incident/problem management (ITIL). Excellent communication, stakeholder management, and technical leadership; ability to mentor and set engineering standards. Technical Stack TrackWise (Sparta Systems/Honeywell). Java or .NET (C#), REST/SOAP services, JSON/XML. Microsoft SQL Server (T-SQL), performance tuning, stored procedures. AWS (e.g., EC2, S3, IAM, CloudWatch) and on-prem connectivity patterns. Docker; scripting/automation with PowerShell; optional Node.js or front-end technologies for UI extensions. Source control and CI/CD (e.g., Git, Azure DevOps/GitHub Actions); environment promotion under CSV constraints. Preferred Skills TrackWise upgrade/migration experience (major version changes, remediation planning, vendor coordination). Hands-on with event-driven architectures, message queues, or integration platforms (e.g., MuleSoft, Boomi). Exposure to other QA/RA systems (e.g., Veeva QMS/RA, Labeling, PLM) and data exchange patterns. Experience with ServiceNow/ITSM, Agile methods (Scrum/Kanban), and regulated SDLC toolchains. Security-by-design mindset (identity/role design, audit trails, segregation of duties). US Benefits at Vantive This is where your well-being matters. Vantive offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical, dental and vision coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Aon Pooled Employer Plan ("Aon PEP"), and Vantive's 401(k) retirement savings plan with a robust set of investment options, education, and resources. Flexible Spending Accounts, educational assistance programs, paid holidays, paid time off (20–35 days based on length of service), family and medical leaves, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Equal Employment Opportunity Vantive is an equal opportunity employer. Vantive evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Knowledge of rights: Workplace Discrimination is Illegal. Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If you need a reasonable accommodation for any part of the application or interview process, please indicate your request and contact information in the form. Recruitment Fraud Notice Vantive has discovered incidents of employment scams where fraudulent parties pose as Vantive employees, recruiters, or other agents. To learn how you can protect yourself, review our Recruitment Fraud Notice.
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