Inizio Engage · 2 days ago
Computer System Validation Coordinator
United States
Full-time
Remote
Mid Level
3+ years expInizio Engage is a strategic, commercial, and creative engagement partner specializing in healthcare, seeking a Computer System Validation (CSV) Coordinator. This role involves ensuring computerized systems comply with regulatory and quality requirements, coordinating validation activities, and maintaining documentation throughout the system lifecycle.
CommercialHealth CareHospital
No H1B
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
Required
Candidates must be authorized to work in the United States without sponsorship now or in the future
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
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
Knowledge of GAMP 5, GxP, 21 CFR Part 11, and data integrity principles
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)
Company
Inizio Engage
Inizio Engage is a healthcare agency that provides decision optimization, experience design, patient solutions, and medical affairs.
5001-10000 employees
Funding
Current Stage
Late StageLeadership Team
Adam Nguyen, MBA
Senior Partner, People & Culture
JESSICA BENNETT, MBA, SHRM-CP
People and Culture Partner
Recent News
2025-08-19
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