$150K — $200K *
We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable – until now.
We don’t follow footsteps. We create the path.
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.
• 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
Valid through: 7/2/2021
$250K — $250K+*