Senior R&D IT Solutions Lead, PLM Systems

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. As we build on our legacy we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services while looking beyond kidney care and 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 believe Vantive will not only build our leadership in the kidney care space it will also offer meaningful work to those who join us. At Vantive you will become part of a community of people who are focused courageous and dont settle for the mediocre. Each of us is driven to help improve patients lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Job Summary:

Vantive is seeking a Senior Technical & Functional professional with expertise in Product Lifecycle Management (PLM) Systems and other R&D application implementations to support digital transformation initiatives. The ideal candidate will be the single point of contact (SPOC) of designated information technology systems including but not limited to hardware software databases & applications.

The ideal candidate will have expertise in PLM architecture and administration the ability to manage customizations and a strong understanding of product development lifecycles in regulated industries such as medical devices healthcare or manufacturing.

Key Responsibilities:

Implementation & Configuration

• Serve as the primary owner and subject matter expert (SME) for PLM systems including its core and extended modules (BOM Change Management Document Control etc.).
• Lead end-to-end implementation of cloning TeamCenter Unified (Siemens) custom SharePoint applications and other apps in R&D by collaborating with SI partners and vendors.
• Perform system configuration customization and validation. Administer user roles access controls licensing and routine system audits to ensure compliance and uptime.
• Develop and implement standard operating procedures (SOPs) templates and user access controls for compliance and efficiency.
• Conduct user training sessions workshops and documentation development to drive system adoption.

System & Incident Management:

• Monitor system performance metrics identify areas of improvement & implement optimization strategies to enhance efficiency and reliability.
• Identify and mitigate risks associated with system operations data integrity and/or cyber security threats.
• Alert and escalate technical issues concerns to functional leads architects and/or program leads.
• Communicate with incident commanders and service desk in accordance with SLAs.
• Implement disaster recovery plans backups and system monitoring.

Continuous Improvement:

• Collaborate with BRM/MRM EA business owners other IT functions and/or with 3rd party system owners on system enhancements and capabilities to translate business requirements into technical designs that are globally scalable aligning with organization road maps goals and initiatives.
• Implement system upgrades and enhancements to improve systems performance functionality and/or security.
• Ensure the system is secure and up to date (patching version certificates etc.) and the system is compliant with authentication policies.

Compliance & Validation Support

• Ensure applications deployments meet GxP and FDA 21 CFR Part 11 standards.
• Assist in computer system validation (CSV) activities including IQ/OQ/PQ documentation and audit readiness.
• Develop and maintain system risk assessments validation scripts and traceability matrices.

Qualifications & Experience:

Required:

• Bachelors degree in computer science Computer Engineering or other related fields.
• 10 years of experience in Information Systems experience in multiple areas of IT.
• 5 years of hands-on experience with PLM systems (Preferred Siemens TeamCenter Unified) including administration customization and integration.
• Strong development skills using C C Java. SPFx C# REST APIs and other supported framework.
• Familiarity with software development tools and methodologies including version controls systems and testing frameworks.
• Understanding of product lifecycle processes including design control change management and document management.
• Experience with administration and maintenance of CI/CD and DevOps tools including managing user accounts performing system upgrades handling license and certificate renewals and ensuring high availability and security compliance across environments.
• Experience working in regulated environments with knowledge of relevant compliance frameworks.

Additional Skills:

• Basic project management experience (Agile Waterfall or hybrid methodologies).
• Strong problem-solving and analytical skills to address complex system issues.
• Excellent communication and stakeholder management skills.

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If because of a medical condition or disability you need a reasonable accommodation for any part of the application or interview process please click on the link here and let us know the nature of your request along with your contact information. Form Link

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