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Computer System Validation Manager Jobs in Claymont, DE

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Computer System Validation Manager information

See Claymont, DE salary details

$46.3K

$102.8K

$156.6K

How much do computer system validation manager jobs pay per year?

As of Aug 11, 2026, the average yearly pay for computer system validation manager in Claymont, DE is $102,840.00, according to ZipRecruiter salary data. Most workers in this role earn between $72,700.00 and $128,800.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a computer system validation manager, and why are they important?

To thrive as a Computer System Validation Manager, you need expertise in computer system validation regulations (such as GxP, FDA 21 CFR Part 11), strong project management skills, and a background in life sciences or IT. Familiarity with validation lifecycle documentation tools, quality management systems (QMS), and compliance software is often required, along with relevant certifications like PMP or CSV-related credentials. Exceptional attention to detail, analytical thinking, and effective communication are crucial soft skills for coordinating cross-functional teams and ensuring regulatory compliance. These skills and qualifications are vital to ensure validated systems meet regulatory standards, minimize compliance risks, and support organizational quality objectives.

What are some common challenges a computer system validation manager faces during system implementation projects?

A Computer System Validation Manager often encounters challenges such as aligning validation activities with evolving regulatory requirements, managing tight project timelines, and coordinating between multiple stakeholders like IT, Quality Assurance, and business users. Ensuring thorough documentation and traceability, while adapting to technology updates or scope changes, can also be demanding. Proactive communication and strong project management skills are essential to mitigate risks and ensure successful, compliant system implementations.

What does a computer system validation manager do?

A Computer System Validation Manager is responsible for ensuring that computer systems used in regulated industries, such as pharmaceuticals or biotechnology, meet all required compliance standards. They oversee the planning, execution, and documentation of validation activities to ensure systems are reliable, accurate, and secure. Their duties include managing validation projects, writing protocols, coordinating with IT and quality assurance teams, and ensuring adherence to regulations like FDA 21 CFR Part 11. This role is critical for maintaining product quality and regulatory compliance.

What is the difference between Computer System Validation Manager vs Computer System Validation Specialist?

AspectComputer System Validation ManagerComputer System Validation Specialist
CertificationsGAMP, CQE, CSQEGAMP, CQE, CSQE
Work EnvironmentManagement, oversight, strategic planningExecution, testing, documentation
Industry UsagePharmaceutical, biotech, regulated industriesPharmaceutical, biotech, regulated industries
Primary FocusLeading validation projects, team coordinationPerforming validation activities, testing

The main difference between a Computer System Validation Manager and a Computer System Validation Specialist lies in their roles. The manager oversees validation projects, manages teams, and ensures compliance, while the specialist executes validation tasks and documents testing procedures. Both roles require similar certifications and are vital in regulated industries like pharmaceuticals and biotech.

What are popular job titles related to Computer System Validation Manager jobs in Claymont, DE? For Computer System Validation Manager jobs in Claymont, DE, the most frequently searched job titles are:
What job categories do people searching Computer System Validation Manager jobs in Claymont, DE look for? The top searched job categories for Computer System Validation Manager jobs in Claymont, DE are:
Computer System Validation Manager jobs near you
Infographic showing various Computer System Validation Manager job openings in Claymont, DE as of August 2026, with employment types broken down into 77% Full Time, 9% Part Time, and 14% Contract. Highlights an 86% In-person, 5% Hybrid, and 9% Remote job distribution, with an average salary of $102,840 per year, or $49.4 per hour.

6424 - Lead Validation Engineer (Data Lake) / CSV Engineer

Verista, Inc.

Conshohocken, PA • On-site

Full-time

Re-posted 16 days ago

Job description

Validation Engineer (Data Lake) Responsibilities:Qualification Strategy & Validation Leadership
  • Lead qualification activities for an enterprise cloud-based Data Lake platform using modern, risk-based CSA methodologies.
  • Assess the current architecture, existing validation deliverables, and identify opportunities to simplify and modernize qualification activities while maintaining compliance.
  • Develop and implement a scalable qualification model supporting future onboarding of GxP systems, data sources, interfaces, and pipelines.
  • Establish sustainable validation and governance procedures supporting both GxP and non-GxP use cases.
Validation Planning & Documentation
  • Author and maintain:
    • Data Lake Validation Plan
    • Requirements Specifications
    • Technical Specifications and As-Built Configuration Documentation
    • Infrastructure Qualification (IQ) Protocols
    • Operational Qualification (OQ) Protocols
    • Validation Summary Reports
    • Test Summary Reports
  • Develop sustainable documentation approaches that leverage platform automation and minimize unnecessary documentation.
Testing & Verification
  • Define streamlined testing strategies focused on critical infrastructure and business processes.
  • Facilitate and coordinate testing activities executed by the Data and Infrastructure teams.
  • Implement targeted verification approaches aligned with CSA principles.
  • Ensure validation deliverables support ongoing lifecycle management and change control.
Governance & Lifecycle Management
  • Develop and implement governance procedures for the enterprise data platform.
  • Establish change control processes supporting:
    • GxP data source onboarding
    • Data pipeline qualification
    • Interface assessments
    • Ongoing platform enhancements
  • Develop Data Lake Administration SOPs and associated work instructions.
  • Support implementation and governance of Power BI solutions used for GxP business processes.
Compliance & Risk Management
  • Ensure alignment with:
    • GAMP 5 Second Edition
    • Computer Software Assurance (CSA) guidance
    • 21 CFR Part 11
    • EU GMP Annex 11
    • Data Integrity requirements
    • Good Documentation Practices (GDP)
  • Leverage supplier assessments, cloud platform controls, and risk-based verification methodologies.
Requirements:
  • Bachelor's degree in Computer Science, Engineering, Information Systems, Life Sciences, or related discipline.
  • 8+ years of Computer System Validation (CSV), CSA, or IT Compliance experience within pharmaceutical, biotechnology, or regulated environments.
  • Strong experience qualifying cloud-based platforms and infrastructure.
  • Demonstrated experience implementing risk-based CSA methodologies.
  • Deep understanding of:
    • GAMP 5 Second Edition
    • FDA CSA Guidance
    • 21 CFR Part 11
    • EU Annex 11
    • Data Integrity principles
    • Change Management and SDLC processes
  • Experience authoring and executing validation documentation.
  • Strong stakeholder management and communication skills.
Preferred Qualifications:

Experience with one or more of the following technologies:

  • Microsoft Azure
  • Azure Data Lake Storage
  • Azure Data Factory
  • Databricks
  • Microsoft Fabric
  • Power BI

Additional preferred experience:

  • Enterprise Data Lakes
  • Data Governance and Data Engineering
  • Analytics Platforms
  • GxP Data Pipelines and Interfaces
  • Infrastructure Qualification
  • SaaS, PaaS, and Cloud Validation
  • Pharmaceutical Manufacturing, Quality, or R&D systems

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