Senior Computer Systems Validation (CSV) Expert Job at Tech3pillars Technologies, Virginia

  • Tech3pillars Technologies
  • Virginia

Job Description

Job Description

Job Title: Senior Computer Systems Validation Expert

Experience: 10+ Years

Domain: Life Sciences / Pharmaceutical / GxP

Must-Have Skills

  • 10+ Years of CSV Experience
  • 10+ Years of SAP System Validation
  • GxP / GMP Regulated Environment
  • CSV / SDLC Practices
  • SAP S/4HANA / BTP / MDG
  • Risk-Based Validation
  • Change Control & Impact Assessment
  • URS / Functional Requirements
  • Validation Protocols & Test Execution
  • Requirements Traceability Matrix (RTM)
  • Data Migration Validation
  • Validation Summary Reports
  • Risk Assessments / DRA
  • Deviation / Discrepancy Management
  • Root Cause Analysis & CAPA
  • Inspection-Ready Documentation

Required Experience

  • Lead CSV activities for large-scale, cross-functional SAP initiatives.
  • Develop and implement risk-based validation strategies.
  • Lead validation risk assessments for system functionality and data flows.
  • Ensure complete traceability from requirements through testing.
  • Coordinate validation activities across Business, Digital, QA, QC, Infrastructure, and vendors.
  • Review test execution and ensure objective validation evidence is properly documented.
  • Investigate deviations, discrepancies, and anomalies and support CAPA/re-testing.
  • Prepare and review key CSV deliverables and ensure compliance with GxP requirements.

Preferred

  • Experience validating AI solutions in a GMP environment
  • CSV leadership for Manufacturing and Supply Chain digital projects
Strong stakeholder management and communication skills

Job Tags

Similar Jobs

A First Choice Staffing Service

Medical Receptionist Job at A First Choice Staffing Service

 ...required. $20-$21 We are looking for an individual, whether entry-level or experienced. This office is willing to train a front desk receptionist to add to their team and cross-train in the billing department. Must be able to demonstrate computer and typing skills with... 

V R Della Infotech Inc

Registered Nurse Job at V R Della Infotech Inc

 ...BLS ACLS PALS NIHSS *pending certs, or certs that expire within 30 days of submission are NOT accepted* Weekend: Every other Holiday: None RTO- no more than 3 days accepted. Hospital Orientation Information: You will... 

Producto

Supply Chain Manager Job at Producto

 ...The Supply Chain Manager is responsible for overseeing and optimizing all supply chain activities across two manufacturing sites, including one international location. This position ensures that raw materials, components, and finished goods move efficiently through the... 

YMCA

Cabin Logistics Coordinator - YMCA Camp Ocoee - Summer 2027 Job at YMCA

 ...opportunity for you! Join our team as a Cabin Logistics Coordinator for summer 2027 (full time/seasonal)! Camp Dates: May 24, 2027 - July 31,...  ...) Y Camp training required before camp sessions, including online safety courses (campers arrive June 1) New Employee... 

Oklahoma Department of Mental Health and Substance Abuse Ser...

Housekeeping / Custodial Worker Job at Oklahoma Department of Mental Health and Substance Abuse Ser...

 ...Housekeeping/Custodial Worker I &II About the Position : Housekeeping/Custodial Workers have the integral role and basic function of the caring for and cleaning of Griffin Memorial Hospital. Positions in this job family are assigned routine work involving sweeping...