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Inizio Engage · 1 day ago

Computer System Validation Coordinator

United States

Full-time

Remote

Mid Level

3+ years exp

Inizio Engage is a strategic engagement partner specializing in healthcare, seeking a Computer System Validation (CSV) Coordinator to ensure compliance with regulatory and quality standards for computerized systems. The role involves coordinating validation activities, maintaining documentation, and facilitating communication among stakeholders to ensure timely completion of validation deliverables.

CommercialHealth CareHospital

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

Qualification

Computer System ValidationGxP Compliance21 CFR Part 11SalesforceMicrosoft Azure DevOpsGAMP 5Agile MethodologiesAnalytical SkillsDocumentation ToolsSoftware Development Life CycleCommunication SkillsProblem-Solving Skills

Required

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

Knowledge of GAMP 5, GxP, 21 CFR Part 11, and data integrity principles

Strong understanding of software development life cycle methodologies (SDLC) and validation processes

Ability to read and interpret system requirements, workflows, and technical documentation

Proficiency with documentation tools, electronic quality systems, or test management platforms

Preferred

Experience in CSV, Quality Assurance, IT Compliance, or regulated system support preferred

Working knowledge of 21 CFR Part 211 is a plus

Past experience working on systems for patient support or access programs preferred

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)