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Computer System Validation Manager Jobs in Pennsylvania

System One Holdings, LLC

System Engineer

Pittsburgh, PA · On-site

Support field issues and system validation as needed Documentation & Configuration Management ... Bachelor's Degree in Engineering, Computer Engineering, or related field required * Master's Degree ...

4 Consulting Inc

Computer Systems Analysts

York, PA · On-site

... management, cybersecurity, infrastructure, or project delivery services for client projects. The ... Gather, analyze, document, and validate business, user, and system requirements to support product ...

4 Consulting Inc.

Computer Systems Analysts

York, PA · On-site

... management, cybersecurity, infrastructure, or project delivery services for client projects. The ... Gather, analyze, document, and validate business, user, and system requirements to support product ...

CYNET SYSTEMS

Lab Support Engineer

West Point, PA · On-site

$41 - $46/hr

Good knowledge of Computer System Validation. * Good understanding of laboratory instruments and ... Manage end to end lab system lifecycle including implementation, validation, maintenance, and ...

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All JobsComputer System Validation Manager JobsComputer System Validation Manager Jobs in Pennsylvania

Computer System Validation Manager information

See Pennsylvania salary details

$47.6K

$105.7K

$160.9K

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

As of Jun 24, 2026, the average yearly pay for computer system validation manager in Pennsylvania is $105,668.00, according to ZipRecruiter salary data. Most workers in this role earn between $74,700.00 and $132,300.00 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 the most commonly searched types of Computer System Validation jobs in Pennsylvania? The most popular types of Computer System Validation jobs in Pennsylvania are:
What are popular job titles related to Computer System Validation Manager jobs in Pennsylvania? For Computer System Validation Manager jobs in Pennsylvania, the most frequently searched job titles are:
What job categories do people searching Computer System Validation Manager jobs in Pennsylvania look for? The top searched job categories for Computer System Validation Manager jobs in Pennsylvania are:
What cities in Pennsylvania are hiring for Computer System Validation Manager jobs? Cities in Pennsylvania with the most Computer System Validation Manager job openings:
Computer System Validation Manager jobs near you
Infographic showing various Computer System Validation Manager job openings in Pennsylvania as of June 2026, with employment types broken down into 2% Locum Tenens, 5% As Needed, 69% Full Time, 9% Part Time, 12% Contract, and 3% Nights. Highlights an 89% Physical, 5% Hybrid, and 6% Remote job distribution, with an average salary of $105,668 per year, or $50.8 per hour.
6407 - Senior CSA Analyst - Plasma Systems & Site Enablement / Senior CSV Engineer

6407 - Senior CSA Analyst - Plasma Systems & Site Enablement / Senior CSV Engineer

Verista, Inc.

King Of Prussia, PA

Other

Posted 8 days ago

Job description

Senior CSA Analyst - Plasma Systems & Site Enablement Responsibilities:Computer Software Assurance & Validation
  • Lead CSA activities for plasma-related applications and systems supporting regulated donor operations and business processes.
  • Develop and execute risk-based validation strategies aligned with CSA principles and industry best practices.
  • Support validation planning, testing, execution, and release readiness for donor-facing and operational support applications, including personalized payment capabilities.
  • Provide CSA oversight for Donor Management System functionality, including enhancements, integrations, configuration changes, and site-specific deployments.
  • Support validation and compliance activities for medical device-related systems and applications.
Compliance & Risk Management
  • Apply risk-based methodologies to assess system criticality, intended use, donor impact, data integrity requirements, and regulatory compliance obligations.
  • Ensure validation activities align with applicable GxP requirements, quality standards, and regulatory expectations.
  • Evaluate system changes, enhancements, and integrations to determine validation scope and testing requirements.
  • Support deviation assessments, defect triage, change control activities, and documentation review processes.
System Implementation & Deployment Support
  • Partner with IT, Quality, Operations, CSA/CSV, business process owners, and project teams to define validation approaches and testing strategies.
  • Support system implementation activities including:
    • Configuration verification
    • Integration testing
    • User Acceptance Testing (UAT)
    • Data migration and data flow assessments
    • Release readiness evaluations
    • Operational readiness activities
  • Assist with cross-functional readiness efforts for systems entering regulated plasma operations environments.
Documentation & Quality Deliverables
  • Author and/or review validation lifecycle documentation, including:
    • Risk Assessments
    • Validation Plans
    • Requirements Specifications
    • Test Strategies and Protocols
    • Traceability Matrices
    • Summary Reports
    • Change Controls
  • Ensure documentation is complete, compliant, and inspection-ready.
  • Guide project teams on appropriate levels of testing rigor, evidence collection, and documentation based on system risk and business impact.
Requirements:
  • Bachelor's degree in Engineering, Computer Science, Life Sciences, Information Systems, or a related discipline.
  • Significant experience in Computer System Validation (CSV) and/or Computer Software Assurance (CSA) within regulated industries.
  • Strong understanding of:
    • GxP computerized systems
    • Risk-based validation methodologies
    • CSA principles and practices
    • Software development and implementation lifecycles
  • Experience supporting regulated system implementations, enhancements, integrations, or change management activities.
  • Demonstrated ability to assess system risk, define validation strategies, and drive deliverables through review and approval.
  • Experience collaborating with Quality, IT, Operations, business stakeholders, and technical teams.
  • Strong knowledge of:
    • Requirements management
    • Test planning and execution
    • Traceability
    • Deviation management
    • Validation reporting
    • Release readiness processes
  • Ability to work independently and effectively across multiple concurrent project workstreams.
Preferred Qualifications
  • Experience in plasma, blood products, biologics, pharmaceutical manufacturing, clinical operations, or medical device environments.
  • Experience with Donor Management Systems or comparable patient-facing, customer-facing, or operational platforms.
  • Knowledge of donor-facing, patient-facing, scheduling, enrollment, intake, payment, or workflow management applications.
  • Experience supporting medical device software, connected devices, instrumentation, equipment interfaces, or regulated data capture systems.
  • Experience supporting:
    • New site startups
    • Facility readiness initiatives
    • Innovation center buildouts
    • Large-scale digital transformation programs
  • Experience with:
    • System integrations
    • Data migration activities
    • Interface testing
    • Data flow assessments
    • Reporting and downstream system impacts
  • Familiarity with:
    • 21 CFR Part 11
    • EU Annex 11
    • GAMP 5
    • Data Integrity requirements
    • Risk-based assurance methodologies

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