IT CSV Analyst (R&D) / Lead Validation Engineer - Remote

Overview

Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

In Short

• Utilize strong BA capabilities and experience with SDLC, system configurations & testing strategies to drive R&D IT system implementations
• Transition from a CSV to CSA approach for software and/or non-instrument related systems
• Lab informatics implementation/validation
• Critical thinking and strategic planning for various validation approaches
• Problem solving in an R&D/regulated environment

Requirements

• 10+ years of direct relevant industry experience
• Must have sound CSV knowledge/technical experience working with the following R&D systems (or similar): Veeva (Quality, RIM, CTMS & Safety), EDC, Shiny apps, Tracelink, Oracle fusion, Pinnacle SAS, GLAMS/AMS
• Must have Gene Therapy experience
• Must have strong BA capabilities as well as experience with SDLC and system configuration & testing strategies
• Experience with LabVantage (Implementation/Validation/Integrations) highly preferred
• Experience with Veeva connector projects and appropriate validation approaches
• Knowledge of Veeva security profiles, configurations, reference lookups, DACs
• Strong communication and critical thinking skills

Benefits

• High growth potential and fast-paced organization with a people-focused culture
• Competitive pay plus performance-based incentive programs
• Company-paid Life, Short-Term, and Long-Term Disability Insurance.
• Medical, Dental & Vision insurances
• FSA, DCARE, Commuter Benefits
• Supplemental Life, Hospital, Critical Illness and Legal Insurance
• Health Savings Account
• 401(k) Retirement Plan (Employer Matching benefit)
• Paid Time Off (Rollover Option) and Holidays
• As Needed Sick Time
• Tuition Reimbursement
• Team Social Activities (We have fun!)
• Employee Recognition
• Employee Referral Program
• Paid Parental Leave and Bereavement