Job Type
Contract Full-Time

Job Description

The Laboratory Information Systems – Business Analyst will provide functional, technical, and project support for the Enterprise Application and Analytics team, working primarily with a LIMS platform and supporting business stakeholders in research, process development, clinical & commercial manufacturing, and quality assurance operations. Major activities include supporting projects to implement a new LIMS platform (both GxP and non-GxP), integrating to laboratory systems (CDS, ELN, LES, SDMS etc.) and technology platforms (ERP, CMMS, MES, etc.), collaborating with DTE and business partners to identify and prioritize areas for opportunity, documenting process flows, gathering and refining requirements, determining options for solution design, delivering enhancements, and managing technology-driven projects and initiatives.

Key Duties and Responsibilities:

  • Work with team members, business partners and other functional groups to understand business processes and the associated systems/data sources in order to deliver optimal technology solutions to meet business goals
  • Gather and document business requirements and user stories from business partners
  • Collaborate with business stakeholders to understand and document their current and future state strategy, process flows, and requirements from a global perspective
  • Proactively offer innovative technologies, solution ideas, and potential business process improvements in pursuit of driving efficiencies and meeting business needs
  • Document and present complex issues, design options and solutions to a variety of audiences
  • Support technology-driven projects, completing assigned tasks, ensuring that deliverables are produced on schedule and with high quality
  • Design, implement and document system configurations for a new LIMS system implementation, including sample management, results analysis, lab workflow, release & stability management, Lab Execution Systems (LES) / Electronic Lab Notebooks (ELN) etc.
  • Participate in the computer system validation (CSV) planning and execution of the solutions, authoring and / or contributing to key system Life cycle (SLC) & CSV deliverables
  • Partner with managed services team members and DTE peers for platform and database support, as well as technical development for enhancements and projects
  • Work closely with DTE Compliance, Internal Audit and Quality Assurance groups as needed to ensure compliance with GxP regulations, as well as our DTE system lifecycle and change management requirements
  • Assist with business process and system testing
  • Assist with data and analytics needs and solution development
  • Assist with system/ enhancement design and implementation
  • Assist with system support, maintenance, and administration

Knowledge and Skills:

  • Experience with commercially available LIMS platforms and large-scale system implementations, upgrades, enhancements, and operational support procedures
  • Demonstrated ability to understand, analyze and document complex business processes, translate business needs and functional requirements into technical or process-driven solutions
  • Experienced and self-directed individual able to work independently and collaboratively in matrixed team environment, lead business users / stakeholders and DTE team members to complete assigned workstream tasks in a timely manner and with expected level of quality
  • Experience in computer system validation, authoring CSV deliverables and execution of testing and validation
  • Strong communication, interpersonal and collaborative skills
  • Solid analytical and problem-solving abilities
  • Solid organizational skills with ability to balance multiple projects and regular workload
  • Good written and verbal communication skills
  • Ability to work effectively as a part of a team and under direct supervision
  • Proficiency in Microsoft Office productivity tools - Excel, Word, PowerPoint
  • Some prior experience with, or conceptual knowledge of through education, business systems analysis techniques (e.g. requirement gathering), programming, and/or system configurations
  • Experience working on Agile Scrum teams preferred

Education and Experience:

  • B.S. and 5+ years relevant work experience
  • Functional/Technical knowledge in quality & laboratory disciplines in the Life Science industry
  • Experience in implementing a major, commercial off the shelf LIMS product in a GxP Quality Control and / or R&D lab environment. Experience with LabVantage a plus.
  • Experience with analytical tools and platforms to document and analyze business process flows, business requirements, functional requirements
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