Compunnel Inc. · 12 hours ago
Computer System Validation Specialist-- KUMDC5725171
Somerset, NJ
Contract
Onsite
Mid Level
$66/hr - $74/hr
4+ years expCompunnel Inc. is collaborating with one of the largest pharma companies in the US to find a Computer System Validation Specialist. The role involves ensuring computerized systems comply with regulatory requirements and company policies, contributing to validation deliverables for computer systems, hardware, and software.
Information Technology & Services
Hiring Manager
Pankaj Kumar Goswami
Responsibilities
Prepare, review, and approve various computer validation documents for CSV projects including the following: Regulatory Assessment for determination of GxP and Part 11 relevance, Validation Plan, Technical Documentation (e.g., User Requirement, Functional Requirements, Design Specifications), Requirements Traceability Matrix, Risk Assessment, IQ/OQ/PQ Protocols, test scripts and Reports, and Validation Summary Report
Review existing validation documentation for the computerized systems used in laboratory and manufacturing floor and retrospectively validate systems as needed
System integration and validation testing for new/enhanced web applications
Testing of data integrations with Trackwise, Empower, SAP and other systems
Perform pre and post review and approval of validation test scripts including test defects
Interface effectively with management personnel in IT, Engineering, Quality, R&D, and other technical disciplines
Provides management with updates on projects, and when necessary, communicates risk-based issue
Provides value-added guidance during the design, deployment, maintenance, and retirement of IT computer system. This guidance applies to all systems developed in house, developed by contractors, and off the shelf (OTS) software. May perform supplemental research to provide options for compliant solutions to barriers encountered during validation
Reviews and approves software validation documentation to ensure documentation is compliant with CSV procedures and all applicable quality system regulations
Exercises judgment in selecting methods and language to provide compliant solutions to address and document issues, which may arise during validation
Ensures that the system’s validation state is maintained throughout the system life cycle
Ensure a high degree of Inspection Readiness for Systems in CSV portfolio with the purpose of minimizing the risk of inspection observations to Business systems/infrastructure within CSV responsibility
Performs a periodic review of systems to monitor the validation status of the system
Other duties as assigned
Qualification
Required
Minimum of 4 years System Development Life Cycle experience, including system integration and validation testing
Software quality assurance
Experience in manual testing
Experience in the Life Sciences industry
Knowledge of FDA regulatory requirements, including 21 CFR Parts 11
Strong understanding of IT network infrastructure and required qualification
Excellent communication (oral and written) and organizational skills
Ability to work independently and in a team setting
Test Automation Tools
Preferred
Experience validating laboratory systems, PLCs and/or SAP is a plus
Company
Compunnel Inc.
Compunnel Inc. is where AI-native solutions meet human ingenuity, helping enterprises reimagine talent, technology, and growth.
5001-10000 employees
H1B Sponsorship
Compunnel Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2276)
2024 (1682)
2023 (1992)
2022 (2366)
2021 (2223)
2020 (2220)
Funding
Current Stage
Late StageLeadership Team
Andy Gaur
Founder, Chairman & CEO
Karthik Natarajan
Executive VP & CTO
Company data provided by crunchbase