Posted:2 months ago| Platform:
Work from Office
Full Time
Job Summary: Vantive is seeking a Senior Technical Functional professional with expertise in Product Lifecycle Management (PLM) Systems and other RD 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 RD 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 SLA s. 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: Bachelor s 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 API s 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. Recruitment Fraud Notice
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