The Senior Computer Systems Validation (CSV) Infrastructure Specialist is responsible for ensuring that the Spark IT infrastructure supporting GxP relevant applications meets or exceeds regulatory expectations for compliant infrastructure platforms, both traditional and cloud based. This includes the qualification and control of IT Infrastructure that is impacted by GxP regulations set forth by the FDA, EU, and other regulatory bodies.
Under the direction of the CSV Lead, the Sr CSV Infrastructure Specialist will lead the overall development and maintenance of risk-based IT Infrastructure lifecycle documentation as specified in the Spark Quality Management System that will provide documented evidence that Sparks GxP IT Infrastructure is compliant and fit for its intended purpose.
40% Develop and manage GxP Infrastructure Qualification lifecycle documentation, including Validation Plans, Specifications, Testing Protocols (IQ), Traceability Matrix, SOPs, Change Control, Risk Assessments, and Validation Reports. Conduct Infrastructure Qualification compliance risk assessments in accordance with Spark standard operating procedure.
30% Support Infrastructure Qualification efforts and act as the primary user/sponsor contact for coordinating work, reporting status, resolving issues, and addressing change control requests as they apply
Support complex technical quality requirements in specific IT Infrastructure and CSV situations, such as validation of new systems, upgrades, changes, or remediation, etc.
30% Provide guidance, interpretation, and ensure compliance with CSV and IT related regulations, quality manuals, company policies, and procedures. Provide technical input to address validation deviations: providing technical assessments for change requests; identifying qualification/validation requirements to ensure GxP compliance; and performing technical reviews of validation deliverables.
Interface with internal stakeholders to analyze data and situations leading to sound decision making.
- Bachelor’s degree in computer science or engineering discipline,
- 10+ years of experience in the field of Computer System Validation and IT Infrastructure Qualification in the Pharmaceuticals, Life Sciences, and Healthcare industries.
- 10+ years’ experience in Good Manufacturing Practice (GMP) / QA within Food and Drug Administration (FDA) regulated environments.
- Demonstrated expertise in at least one aspect of system qualification and regulatory compliance (e.g., FDA, EMEA, GCP, GLP, GMP, QSR, etc.) and internal requirements employing regulatory guidance and industry standards.
- Working knowledge and the practical application of the following:
- GAMP 5 risk-based approach to compliant computerized systems.
- GAMP Good Practice Guide for IT Infrastructure Control and Compliance
- Experience with FDA 21 CFR Part 11 compliance.
- Experience with Eudralex, Volume 4 - Annex 11 compliance.
- Ability to communicate verbally and especially in writing at a professional level and to distill complex technical terms to a layperson's understanding with conciseness, clarity, and accuracy. Excellent writing skills (functional/technical specifications) are required.
- Strong relationship building skills and ability to work well in a multi-cultural environment.
- Demonstrates attention to detail and possess strong analytical skills.
- Possess the ability to multitask and work independently or in a team environment with minimal supervision
• Possess good interpersonal and strong written/verbal communication skills
• Well developed skills in prioritizing, organization, and time management
• Highly motivated and detail oriented with good organizational skills
• Ability to work in a dynamic, fast paced environment with shifting priorities
Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.
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