The Shire Device Center of Excellence (DCoE) based in Lexington, Massachusetts allows Shire to explore how next generation therapeutics, emerging technologies and new care models can improve patient health. Our team shares a passion for challenging conventional wisdom and creating an environment that embraces the risk-reward aspects of developing breakthrough concepts. The DCoE offers a start-up environment with large company support. The DCoE works closely with research and development, commercial, device and drug product teams, and key external partners to drive early stage device/delivery system initiatives from concept to launch.
This Technical Team member will assist in managing the deployment of eHealth and Connected Health platforms and applications (e.g., mobile / web applications, infrastructure, middleware, and network, etc.). As a hands-on technical operations subject matter expert (SME), this person will assist in the day-to-day management of technical assets. Operational run activities will include maintaining the over-all platform health such as monitoring, performance, release management, and standard maintenance. The role will assist in operational activities across multiple device platforms and interact with multiple vendors (some platforms are 24X7). The role will be responsible for assisting in meeting all device Service Level Agreements (SLAs) and respond in timely manner to post-market questions and issues. Area of focus will include continuous improvement and automation of all aspects of the software medical device platform following good documentation practices and quality procedures. This role will follow the device design control and IT technical standards policies and procedures for delivery. This role will assist in audit / inspections and requires adherence to Shire’s compliance policies and procedures.
This individual is expected to have strong troubleshooting and scripting skills, Unix/Linux server administration experience, apache web administration and configuration, understanding of web applications and databases, and the ability to work with a globally distributed team.
Responsibilities (% of time):
Application Release deployments – project execution
- Assist in the Dev/Ops organization overseeing the build, runtime configuration and deployment of the Spring Cloud Microservices, Spring MVC/Angular JS website, iOS and Android Mobile Applications, and MySQL and Couchbase databases.
- Assist in providing quarterly reports of connected device performance / health
- Assist in responding to post market surveillance issues (e.g., product complaints, CAPAs, FCA, etc.) – as assigned.
- Assist in responding and implementing compliance changes in a timely manner.
- Demonstrate work and team activities are aligned with all relevant quality, regulatory, and GXP requirements.
- Collaborate with the support teams ensuring the health and availability of the non-production and production runtime environments.
- Be a contributor of assigned cross functional team and contribute to the implementation of defined strategic initiatives for digital health and connectivity.
Technology Asset / Release Management
- Responsible for maintaining release management calendar for routine upgrades and maintenance.
- Responsible for maintaining comprehensive asset inventory.
- Assist in the management of build tools (Jira, Jenkins, Maven, Artifactory, SVN, SonarQube).
Assessment / Continuous Improvement activities
- Assist in providing input into the assessment of technologies as part of the long-range architecture based on pipeline and industry trends
- Assist in the identification, development, and release of technical and operational improvement ideas
- Assist in vendor management
- Assist in vendor assessments
- 5+ years of technical experience in architecture and / or operational run activities (e.g., mobile / web applications, infrastructure, middleware, and network, etc.).
- Experience in environment build, runtime configuration and deployment of key technologies across multiple applications / devices in production in global environment.
- Experience in connected devices and / or regulated validated system development a plus.
- Experience with Jira, Jenkins, Maven, Artifactory, SVN for Continuous Integration and Deployment (or similar tools).
- Working knowledge of Cloud IaaS/PaaS.
- Exposure to applying Security for Cloud Hosted Applications that handle PHI/PII data.
- Experience in asset management and inventories a plus.
- Experience in working with on / off shore resource support model
- Experience in technical application development skills a plus.
Key Skills and Competencies:
- Exposure to IaaS, PaaS, SaaS
- Experience with Apache Web Server Configuration, understanding of Java Web Applications and databases
- Experience with Jira, Jenkins, Maven, Artifactory, SVN, SonarQube or similar tools
- Experience in working with globally distributed teams
- Good written and oral communication skills
Req ID: R0020080