Job
Description
Domain SME / BA For Manufacturing For LS Job Summary: Senior Business Analyst with strong domain expertise in Life Sciences manufacturing. This hybrid role blends the analytical rigor of a BA with the strategic insight of a Subject Matter Expert (SME). You will collaborate with clients to analyze business needs, define compliant and scalable technology solutions, and bring industry best practices to digital transformation initiatives. Key Responsibilities Business Analysis & Solution Design: Elicit, analyze, and document business and functional requirements from Life Sciences manufacturing stakeholders. Translate client needs into actionable user stories, use cases, and process flows for development and solutioning teams. Collaborate with architects and delivery teams to design solutions aligned with manufacturing operations and regulatory standards. Domain Advisory Act as a trusted advisor to clients by providing insights into industry best practices across GMP, batch processing, MES, QA/QC, and shop floor integration. Guide clients in aligning technology solutions with compliance requirements (e.g., 21 CFR Part 11, GAMP 5, GMP). Contribute to validation strategies and regulatory readiness for digital systems. Client Engagement & Pre-Sales Support Participate in discovery workshops, assessments, and solution ideation sessions with prospective clients. Support proposal development with domain input, business case justifications, and solution outlines. Help craft roadmaps for digital transformation initiatives, particularly around MES, ERP, LIMS, or other manufacturing IT systems. Thought Leadership & Enablement Stay up-to-date with Life Sciences manufacturing trends and bring forward innovative ideas (e.g., digital twins, real-time release, AI in QA). Contribute to internal knowledge repositories and mentor junior BAs or team members on domain topics. Required Qualifications Bachelor degree in Life Sciences, Engineering, or a related field. 8+ years of experience as a Business Analyst, with 3+ years in the Life Sciences manufacturing domain. Deep understanding of manufacturing operations, systems (MES, ERP, LIMS), and regulatory frameworks. Strong communication and collaboration skills and the ability to work with both business and technical stakeholders. Proficiency in tools such as Visio, JIRA, Confluence, and data visualization/reporting platforms Show more Show less
