Inizio Engage
Computer System Validation Coordinator
This job is now closed
Job Description
- Req#: JR34969
Employer Industry: Healthcare
Why consider this job opportunity:
- Competitive compensation
- Excellent benefits package including accrued time off, medical, dental, vision, 401k, disability & life insurance, and paid maternity and paternity leave
- Recognition programs, contests, and company-wide awards
- Exceptional, collaborative culture recognized as one of the Best Places to Work in BioPharma (2022, 2023, & 2024)
- Flexible work environment allowing remote work from any city
What to Expect (Job Responsibilities):
- Coordinate Computer System Validation (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
- Facilitate communication between Digital, Quality and Compliance, vendors, and system owners to ensure alignment on validation tasks and timelines
- Prepare, review, and maintain validation documentation, including protocols (IQ/OQ/PQ), reports, test scripts, and change control records
- Ensure validation deliverables meet regulatory expectations and internal SOPs
What is Required (Qualifications):
- Bachelor’s Degree or related work experience
- At least 3 years of experience in a direct CSV role in a regulated environment
- Experience working with Salesforce (preferably Health Cloud) and Microsoft Azure DevOps
- Strong understanding of Agile methodologies
- Excellent analytical, communication, and problem-solving skills
How to Stand Out (Preferred Qualifications):
- Experience in CSV, Quality Assurance, IT Compliance, or regulated system support
- Knowledge of GAMP 5, GxP, 21 CFR Part 11, and data integrity principles
- Working knowledge of 21 CFR Part 211
- Past experience working on systems for patient support or access programs
- Proficiency with documentation tools, electronic quality systems, or test management platforms
#Healthcare #CSV #QualityAssurance #RemoteWork #CareerOpportunity
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