Business Analyst – GxP, Computer System Validation

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Take charge of and manage the GxP validation package, which includes around 20 validation documents.

• Gather, analyze, and document both business and system requirements, covering URS, functional requirements, process flows, and requirements traceability.

• Categorize validation documents as either narrative or state-derived.

• Write narrative documents and ensure the maintenance of supporting evidence.

• Create and uphold validation documentation in compliance with GAMP 5, CSV, and GxP standards.

• Assist in and oversee IQ/OQ/PQ validation processes, which involve test documentation, evidence gathering, review, and traceability.

• Conduct risk assessments, gap analyses, change controls, and impact assessments for validated systems and processes.

• Keep up with validation evidence, traceability matrices, deviations, CAPA documentation, periodic reviews, and other compliance records.

• Work collaboratively with business, IT, quality, and validation teams to ensure readiness for regulatory and audit processes.

⛳️ Requirements

• Over 8 years of experience in Software/Data Engineering, Business Analysis, Computer System Validation, or a similar role within regulated environments.

• Proven experience in pharmaceutical, life sciences, or other GxP-regulated settings.

• Familiarity with requirements gathering, URS development, functional/business requirements, process mapping, and requirements traceability.

• Practical experience in Computer System Validation (CSV).

• In-depth understanding of GAMP 5 principles.

• Acquainted with validation documentation and lifecycle activities, including URS/FS/DS, IQ/OQ/PQ, risk assessment, validation strategies, and test documentation.

• Experience in supporting regulatory audits and maintaining validation evidence that is audit-ready, including change controls, deviations, CAPA, and periodic reviews.

• Proficient in technical documentation and authoring.

• Skilled in managing controlled validation documentation and complete validation packages.

• Strong stakeholder management, communication, analytical, and organizational abilities.

• Capability to collaborate across business, technical, quality, and compliance teams.

🏝️ Benefits

• Options for remote work.

• A dynamic, non-hierarchical work environment.

• Employee ownership and a culture of open collaboration.

• An opportunity to make a meaningful impact.

• Collaborate with global teams across 39 countries.