Sr. Computer Systems Validation Infrastructure Specialist
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.Requirements
- 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
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.
Nearest Major Market: Philadelphia
Join the Spark Team
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.