Business Analyst - Pharma LIMS & ELN

Capgemini • New York, NY

11d • Hybrid

About The Position

We are seeking an experienced Business Analyst with a strong background in BioAnalytical laboratory processes and hands-on involvement in LIMS/ELN implementations, ideally LabVantage LIMS. The selected candidate will play a critical role in gathering requirements, defining workflows, and supporting the design and implementation of LIMS, ELN, Reagent Management, and Analytics capabilities for our pharmaceutical client.

This is a hybrid role, with on-site presence occasionally required in Spring House, PA

Requirements

• 3+ years of documented experience in a business analyst or PMO role in pharmaceutical or life sciences organizations, or other relevant laboratory experiences in pharmaceutical or life sciences organizations.
• Deep understanding of laboratory process in pharmaceutical product development
• Hand-on experience implementing LIMS/ELN solutions
• Experience in practical data analytics, using insights to support operational experience and improvements
• Familiarity with relevant regulatory guidelines (GxP, 21 CFR Part 11, data integrity ALCOA+ principles)

Responsibilities

• Work closely with scientists, lab managers, QA, and IT stakeholders to capture detailed business requirements for BioAnalytical workflows.
• Analyze current state processes and define future-state workflows aligned with LabVantage capabilities.
• Translate scientific and operational needs into functional and technical specifications.
• Support configuration, customization, and deployment of LabVantage LIMS and ELN modules.
• Define test cases, support UAT, and ensure system validation aligns with GxP requirements.
• Help map BioAnalytical processes such as sample preparation, assay execution, method validation, result review, and data lifecycle management.
• Document reagent lifecycle processes including creation, qualification, expiry tracking, and usage logging.
• Work with lab teams to implement traceable and compliant reagent management workflows.
• Collaborate with data analytics teams to design dashboards and reporting structures.
• Define data models and KPIs to support operational insights and regulatory needs.
• Ensure all requirements and design documentation meet pharma regulatory guidelines (GxP, 21 CFR Part 11, data integrity ALCOA+ principles).
• Support audit readiness for the system once implemented.

Benefits

• Paid time off based on employee grade (A-F), defined by policy: Vacation: 12-25 days, depending on grade, Company paid holidays, Personal Days, Sick Leave
• Medical, dental, and vision coverage (or provincial healthcare coordination in Canada)
• Retirement savings plans (e.g., 401(k) in the U.S., RRSP in Canada)
• Life and disability insurance
• Employee assistance programs
• Other benefits as provided by local policy and eligibility

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed
• Number of Employees: 5,001-10,000 employees