Business Systems Analyst II
On-site · New Albany, Ohio, United States
Job Summary
The Business Systems Analyst II translates business needs into system requirements for GxP-regulated computerized systems, supports lifecycle activities including validation across IQ/OQ/PQ/UAT, and ensures data integrity and regulatory compliance. This role collaborates with IT, QA, Quality, and business stakeholders to document URS, risk assessments, FS, CS, SS, DS, and validation plans, and participates in audits and inspections. It requires strong elicitation and documentation skills, familiarity with FDA/ICH/GAMP data integrity expectations, and experience with validated COTS platforms and CSV concepts. The analyst contributes to ongoing SOP development and supports system changes, upgrades, and retirement activities within a regulated pharmaceutical environment.
Required Qualifications
- Bachelor’s degree in Information Systems, Engineering, Business, Computer Science, or STEM related discipline (or equivalent experience)
- 3–6 years of experience as a Business Systems Analyst, Business Analyst, Computer System Validation or similar role
- Hands‐on experience supporting administrative activities for validated or GxP‐regulated computerized systems
- Experience working within SDLC and CSV frameworks in a pharmaceutical, biotech, or other regulated environment
- Strong requirements elicitation and documentation skills in regulated environments
- Working knowledge of CSV concepts, including requirements, risk management, and traceability
- Strong understanding of FDA, EU, GAMP, ICH and data integrity expectations for computerized systems
- Ability to apply risk‐based thinking to validation and system changes
- Strong analytical, organizational, and problem‐solving skills
- Clear written and verbal communication suitable for audits and inspections
- Ability to manage multiple priorities while maintaining compliance rigor
- Experience with FDA Computer Software Assurance (CSA) and Computer Software Validation (CSV) principles
- Experience supporting validated COTS platforms (e.g., LIMS, QMS, ERP, TrackWise, Veeva, SAP, MES, Empower, OpenLab, Chromeleon)
- Experience with change control, periodic reviews, and system retirement activities
- Experience using validation lifecycle management tools (e.g., Res_Q, ValGenesis, KNEAT)
- Physically able to wear cleanroom/protective gowning and equipment, including gowning, goggles, face shields, and protective gloves
- PPE is essential for health and safety of employees
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