Vantive is seeking a Senior Techno-Functional Consultant with expertise in R&D application implementations to support digital transformation initiatives. The ideal candidate will be the SPOC of designated information technology systems, including but not limited to hardware, software, databases, & applications.
The ideal candidate will have expertise in R&D Application management 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:
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.
- Support internal and external audits by providing system documentation, access reports, and validation artifacts as required
- Develop and maintain system risk assessments, validation scripts, and traceability matrices.
Implementation & Configuration
- Serve as the primary owner and subject matter expert (SME) for R&D Applications, including its core and extended modules
- 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.
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 R&D systems, including administration, customization, and integration.
- Ensure the system is secure and up to date (patching, version, certificates etc.,) and the system is compliant with authentication policies.
- Proven experience operating in multi-region environments (EMEA,APAC,LATAM) and hybrid cloud/on-premises architecture
- 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.
