CSV Validation Engineer - Pharma / Life Science

Overview

On Site
Depends on Experience
Accepts corp to corp applications
Contract - W2
Contract - Independent
Contract - 12 Month(s)

Skills

Acceptance Testing
GMP
GxP
KPI
LIMS
Life Sciences
MES
QMS
Regulatory Affairs
Regulatory Compliance

Job Details

Overview
We are seeking a highly analytical and collaborative Business Analyst to support strategic initiatives within the pharmaceutical and life sciences sector. This role partners closely with cross-functional teams in R&D, Quality, Regulatory Affairs, Manufacturing, and IT to analyze processes, gather requirements, and drive data-driven solutions that enhance efficiency, compliance, and decision-making across the organization.
The ideal candidate has strong experience working in regulated environments (GxP, GMP, or FDA-compliant settings) and is comfortable bridging the gap between business users and technical teams.
Key Responsibilities
Collaborate with business stakeholders across R&D, Quality, Regulatory, Supply Chain, and IT to gather, document, and translate requirements into actionable technical specifications.
Develop and maintain Business Requirement Documents (BRDs), Functional Specifications, and User Storiesfor system enhancements, new applications, and process improvements.
Analyze current-state workflows and identify opportunities for efficiency, automation, and data quality improvement.
Support implementation and validation of GxP-compliant systems, ensuring alignment with CSV (Computer System Validation) and 21 CFR Part 11 requirements.
Partner with data and reporting teams to develop dashboards, KPIs, and visual insights supporting clinical, quality, and operational reporting.
Facilitate workshops and working sessions to ensure clear communication between business and technical teams.
Participate in UAT (User Acceptance Testing) and support post-implementation activities including change management and training.
Track and manage project timelines, risks, and deliverables within an Agile or hybrid project environment.
Qualifications
Bachelor s degree in Life Sciences, Business, Information Systems, or related field.
3 7 years of experience as a Business Analyst in pharmaceuticals, biotechnology, or medical deviceindustries.
Working knowledge of GxP, GMP, and regulatory compliance frameworks.
Experience with CSV processes and validation documentation.
Proficiency in Excel, Power BI, Tableau, or similar analytical/reporting tools.
Familiarity with ERP, LIMS, MES, or QMS systems (e.g., SAP, LabWare, MasterControl, Veeva).
Excellent analytical, documentation, and communication skills.
Preferred Skills
Experience supporting system implementations or upgrades (e.g., ERP, QMS, LIMS, or electronic batch record systems).
Understanding of data integrity principles and audit-readiness.
Knowledge of SDLC and Agile delivery methodologies.
Exposure to AI, automation, or data governance initiatives within life sciences.
Ability to bridge technical and non-technical discussions effectively.

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