Business/Systems Analyst

Location: Indianapolis, IN (onsite 5 days per week)

Project Details:

Acts as the analytical bridge between scientific subject matter experts and data engineering teams to facilitate, document, and speed up data collection. This role maps the digital thread by defining how device validation data, design history files, and lab informatics link together across the product lifecycle. 

Key Responsibilities

·        Gather, analyze, and document business, system, and data requirements across the business

·        Map current processes and data flows; identify gaps, manual handoffs, and efficiency opportunities

·        Map end-to-end business workflows and data flows across the full lifecycle: Planning, Design, V&V (Verification and Validation), Transfer, and Regulatory Submission. Identify data re-entry steps and manual gaps between distinct systems.

·        Develop requirements traceability matrices and support stakeholder alignment

·        Create data flow diagrams, process maps, gap analyses, and data domain documentation

·        Assess system integration, data architecture gaps, and external partner data exchange requirements

·        Evaluate and recommend ELN platforms (e.g., Signals, Benchling) based on business needs

·        Serve as the liaison between business stakeholders and engineering teams during implementation

·        Document data requirements across key domains including container/closure components, ISO 11608-1 EPR parameters, human factors (HF) study records, and device component hierarchies.

MUST HAVE experience:

·        5+ years of experience in business, systems, or data analysis

·        Experience in pharmaceutical, biotechnology, medical device, or combination product development

·        Proven ability to produce clear, actionable documentation for engineering and IT teams

·        Requirements gathering through interviews, workshops, process observation, and document analysis

·        Strong familiarity with regulated life science IT systems, including Laboratory Information Management Systems (LIMS), Electronic Lab Notebooks (ELN), Product Lifecycle Management (PLM), and Document Management systems.

·        Process mapping, data flow analysis, gap assessments, and data dictionary development

·        Strong stakeholder management and communication skills

·        Ability to translate business and regulatory requirements into technical specifications

·        Experience with conducting structured workshops with Engineering disciplines (Mechanical, Systems, Materials, Electrical/Software, and Human Factors) to translate domain knowledge into precise data requirements for architectural design. 

·        GxP Compliance: Practical working knowledge of GxP data integrity principles (ALCOA+) and their implications for design controls, Design History Files (DHF), and Common Technical Document (CTD) regulatory structures.