Computer System Validation Coordinator

Inizio Engage • Yardley, PA

4d • Remote

About The Position

Inizio Engage is seeking a Computer System Validation (CSV) Coordinator to ensure that all computerized systems used within the organization are implemented, maintained, and operated in compliance with regulatory, quality, and data integrity requirements. This role provides coordination, documentation control, and project support for validation activities across the system lifecycle—from planning and risk assessment through testing, approval, and periodic review. The CSV Coordinator works closely with Digital, Quality, and business stakeholders to ensure that validation deliverables are completed on time, accurately reflect system requirements, and meet internal procedures as well as industry standards (e.g., GxP, 21 CFR Part 11, GAMP 5). By enabling compliant and reliable system performance, the CSV Coordinator helps safeguard product quality, patient safety, and regulatory readiness.

Requirements

• Bachelor’s Degree or related work experience, required.
• At least 3 years of experience in a direct CSV role and in regulated environment, required.
• Experience working with Salesforce (preferably Health Cloud) and Microsoft Azure DevOps.
• Strong understanding of Agile methodologies.
• Excellent analytical, communication, and problem-solving skills.
• Experience in CSV, Quality Assurance, IT Compliance, or regulated system support preferred.
• Knowledge of GAMP 5, GxP, 21 CFR Part 11, and data integrity principles.
• Working knowledge of 21 CFR Part 211 is a plus.
• Strong understanding of software development life cycle methodologies (SDLC) and validation processes.
• Past experience working on systems for patient support or access programs preferred.
• Ability to read and interpret system requirements, workflows, and technical documentation.
• Proficiency with documentation tools, electronic quality systems, or test management platforms.

Responsibilities

• Coordinate CSV activities for new systems, upgrades, and changes throughout the system lifecycle.
• Support the development of validation plans, risk assessments, requirements specifications, and traceability matrices per client.
• Facilitate communication between Digital, Quality and Compliance, vendors, and system owners to ensure alignment on validation tasks and timelines.
• Working with the CSV Lead, prepare, review, and maintain validation documentation, including protocols (IQ/OQ/PQ), reports, test scripts, and change control records.
• Ensure validation deliverables meet regulatory expectations (GxP, 21 CFR Part 11, Annex 11) and internal SOPs.
• Maintain system validation files and ensure documentation is audit-ready and properly archived
• Execution of test script (IQ/OQ/PQ) and capturing and documenting all Bugs.
• Support periodic reviews, re-validation assessments, and ongoing monitoring of validated systems.
• Assist with change control processes, ensuring that system changes are assessed for validation impact.
• Help ensure configuration management and version control practices are followed
• Assist with internal and external audits

Benefits

• Competitive compensation
• Excellent Benefits – accrued time off, medical, dental, vision, 401k, disability & life insurance, paid maternity and paternity leave benefits, employee discounts/promotions
• Employee discounts & exclusive promotions
• Recognition programs, contests, and company-wide awards
• Exceptional, collaborative culture
• Best Places to Work in BioPharma (2022, 2023, & 2024)
• Certified Great Place to Work (2022, 2023, 2025)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level