Domain SME / BA for Manufacturing for LS:Job Summary: Senior Business Analyst with strong domain expertise in Life Sciences manufacturing. This hybridrole blends the analytical rigor of a BA with the strategic insight of a Subject Matter Expert (SME). You will collaborate with clients to analyze businessneeds define compliant and scalable technology solutions and bring industry best practices to digital transformation :Business Analysis & Solution Design:Elicit analyze and document business and functional requirements from Life Sciences client needs into actionable user stories use cases and process flows for development and solutioning witharchitects and delivery teams to design solutions aligned with manufacturing operations and regulatory Advisory:Act as a trustedadvisor to clients by providing insights into industry best practices across GMP batch processing MES QA/QC and shop floor clients inaligning technology solutions with compliance requirements (e.g. 21 CFR Part 11 GAMP 5 GMP).Contribute to validation strategies and regulatoryreadiness for digital Engagement & Pre-Sales Support:Participate in discovery workshops assessments and solution ideation sessions withprospective proposal development with domain input business case justifications and solution craft roadmaps for digitaltransformation initiatives particularly around MES ERP LIMS or other manufacturing IT Leadership & Enablement:Stay up-to-date withLife Sciences manufacturing trends and bring forward innovative ideas (e.g. digital twins real-time release AI in QA).Contribute to internal knowledgerepositories and mentor junior BAs or team members on domain Qualifications:Bachelor degree in Life Sciences Engineering or a relatedfield.8 years of experience as a Business Analyst with 3 years in the Life Sciences manufacturing understanding of manufacturingoperations systems (MES ERP LIMS) and regulatory communication and collaboration skills and the ability to work with bothbusiness and technical in tools such as Visio JIRA Confluence and data visualization/reporting platforms
Required Experience:
Senior IC