Business Analyst – GxP, Computer System Validation

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

📋 Description

• Take ownership and manage the GxP validation package, which comprises approximately 20 validation documents.

• Ensure the validation package is complete, consistent, and prepared for audits.

• Elicit, analyze, and document business and system requirements, including User Requirement Specifications (URS), functional requirements, process flows, and traceability of requirements.

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

• Write narrative documents and ensure that relevant supporting evidence is properly maintained.

• Develop and sustain validation documentation in compliance with GAMP 5, CSV, and GxP standards.

• Assist and coordinate Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) validation activities, which include test documentation, evidence gathering, review, and traceability.

• Conduct risk assessments, gap analyses, change control, and impact assessments pertaining to validated systems and processes.

• Maintain validation evidence, traceability matrices, deviations, Corrective and Preventive Action (CAPA) documentation, periodic reviews, and other compliance records.

• Collaborate with business, IT, quality, and validation teams to ensure thorough regulatory and audit readiness.

⛳️ Requirements

• A minimum of 8 years of experience in Business Analysis, Computer System Validation, or a similar role in regulated environments.

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

• Strong background in requirements elicitation, URS development, functional/business requirements, process mapping, and traceability of requirements.

• Practical experience with Computer System Validation (CSV).

• In-depth knowledge of GAMP 5 principles.

• Comprehensive understanding of validation documentation and lifecycle activities, including URS/FS/DS, IQ/OQ/PQ, risk assessment, validation strategy, and test documentation.

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

• Exceptional skills in technical documentation and authoring.

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

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

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

🏝️ Benefits

• Remote work arrangement.

• Full-time employment.