IT CSV Analyst (R&D) / Lead Validation Engineer
A leading consulting firm in the life sciences sector is seeking an experienced IT CSV Analyst to support R&D system implementations and validation initiatives. This role offers the opportunity to work on high-impact projects that contribute to innovation and compliance in regulated environments.
About the Organization:
This firm partners with some of the most prominent names in the pharmaceutical and biotech industries, delivering expert consulting services that drive operational excellence, regulatory compliance, and digital transformation. Their team is composed of professionals who are passionate about advancing healthcare through technology and collaboration.
Core Values & Culture:
- Empowering and supporting team members
- Prioritizing client success through every engagement
- Acting with integrity and accountability
- Fostering an inclusive, respectful, and growth-oriented environment
- Embracing continuous learning and knowledge sharing
Role Responsibilities:
- Lead and support R&D IT system implementations with a focus on Computer System Validation (CSV) and Computer Software Assurance (CSA) methodologies
- Apply business analysis skills to define system requirements, configurations, and testing strategies
- Contribute to lab informatics projects, including implementation and validation
- Develop strategic validation approaches tailored to regulated environments
- Troubleshoot and resolve issues in complex R&D system landscapes
Qualifications:
- 10+ years of relevant experience in the life sciences industry
- Strong expertise in CSV and CSA practices, particularly for R&D systems
- Hands-on experience with platforms such as Veeva (Quality, RIM, CTMS, Safety), EDC, Shiny apps, Tracelink, Oracle Fusion, Pinnacle SAS, and GLAMS/AMS
- Background in gene therapy environments is required
- Proficiency in SDLC, system configuration, and validation testing
- Experience with LabVantage (implementation, validation, and integration) is highly desirable
- Familiarity with Veeva connector projects, including validation strategies and security configurations
- Excellent communication, analytical, and problem-solving skills
This is a fantastic opportunity for a seasoned validation professional to contribute to meaningful projects in a dynamic and supportive consulting environment.
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