Validation Lead

Validation Lead at SIMARN Solutions Validation Lead at SIMARN Solutions in Bridgewater, New Jersey Posted in about 16 hours ago.

Type:

full-time

Job Description:

IM Regulatory Validation Lead Experience:

7+

Years Location:

Raritan, New Jersey, Hybrid Note:

U.S. work authorization required (USC or Green Card on W?2 payroll only). Role We are looking for an experienced Validation Lead to take end?to?end ownership of validation activities for a Unified Regulatory Platform (URP) built on Veeva and AWS cloud stack .

Key Responsibilities:

Act as the single point of accountability for all validation deliverables Author key validation documents including: Validation/Compliance Plan, Validation Reports, Requirements Traceability Matrix (RTM), Data Flow Maps, Change Controls. Define and execute validation strategies for projects Provide guidance on SDLC and CSV best practices Support audit readiness and application lifecycle management Lead change control processes and coordinate go?live activities Collaborate with and guide cross-functional teams

Required Skills & Experience:

7-9 years of experience in: Computer System Validation (CSV) Quality Management or Business Analysis in GxP environments Strong understanding of GxP regulations, GCP, and

FDA 21 CFR

Part 11 Hands-on experience with validation and testing Proficiency in tools such as JIRA, qTest, ServiceNow (SNOW) Solid knowledge of Agile/iterative development methodologies Strong skills in Risk management & mitigation, Project planning & execution, and Analytical thinking & problem-solving

Qualifications:

Bachelor's degree in

Technology or Engineering Preferred:

Prior experience with Johnson & Johnson (J&J) environments