Support/Implementation Specialist, Intern
apexanalytix
ERPSDLCSQLTableau
Senior IT Application Architect, LIMS
Edwards Lifesciences
full-time
Posted on:
Origin: • 🇺🇸 United States • California, Colorado, New York, Ohio
Visit company websiteSalary
💰 $136,000 - $192,000 per year
Job Level
Senior
Tech Stack
ERPSDLCSQL
About the role
- Design and implement LIMS technical solutions to meet business requirements
- Oversee all technical delivery for LIMS and assume technical ownership of the system
- Define and implement IT LIMS standards, ensuring alignment with global IT and industry best practices
- Manage the technical platform roadmap, including regular platform updates and prompt resolution of IT security vulnerabilities within SLAs
- Advocate for remediation of technical debt and continuous system improvements
- Partner with business leaders to understand organizational needs and assess implementation complexity for initiatives
- Act as a steward for LIMS integrity, minimizing unnecessary customization and preserving system purpose
- Execute a shift-left strategy for support and maintenance: transfer Level 2 support to global team while retaining Level 3 support, problem management, and change management within the transformation team
Requirements
- Bachelor's Degree in Computer Science, Information Systems, Natural Sciences & Mathematics or a related discipline
- A minimum of ten years experience in IT
- A professional certification (e.g. TOGAF, COBIT, ITIL, OCP, CDMP, etc.) in related disciplines and architecture frameworks
- Hands-on experience designing, configuring, implementing, and maintaining enterprise LIMS (preferred LabWare and LabVantage)
- Experience working with 21 CFR part 11
- Experience in a regulated environment and strong understanding of GxP concepts and regulatory compliance in a pharmaceutical/medical device setting
- Experience with commercial off the shelf applications and master data structure considerations
- Experience writing and executing validation deliverables (e.g., IQ/OQ/SDD) in the SDLC for validated, regulated applications
- Strong background in server-client and/or web hosted application architecture, integrations to applications and equipment
- Experience with laboratory instruments and enterprise systems (such as ERP and MES)
- Server administration experience required to support an enterprise application
- Experience with structured query language (SQL) and relational databases
- Experience/knowledge with remote desktop and other web hosting platforms
- Experience working with application vendors and 3rd party consulting companies on technology implementations and delivery
- Comfortable communicating and presenting ideas/recommendations to senior leadership
- Experience working in a global, highly matrixed, team-oriented IT environment
- High energy, self-motivation, results-driven mindset
- COVID-19 vaccination may be required for patient-facing and in-hospital roles (unless accommodation granted)
