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Computer System Validation Manager Jobs (NOW HIRING)

CAI

Computer Systems Validation Engineer

Baltimore, MD · On-site

$75K - $106K/yr

We provide commissioning, qualification, validation, startup, project management, and other ... System & Industry Expertise Support CSV activities across various platforms including MES, DCS ...

Spruce Infotech

Validation Expert

Fort Worth, TX · On-site

Work with project management to build an integrated project plan inclusive of the required Computer System Validation (CSV) Lifecycle Deliverables, quality gates and summarization milestones.

Valspec

Validation Engineer (CSV)

Redmond, WA

Lead Computer System Validation (CSV) activities for DeltaV-based manufacturing systems. * Develop and execute validation deliverables including: * Validation Plans * Risk Assessments * Requirements ...

Valspec

Validation Engineer (CSV)

Seattle, WA

Lead Computer System Validation (CSV) activities for DeltaV-based manufacturing systems. * Develop and execute validation deliverables including: * Validation Plans * Risk Assessments * Requirements ...

Actalent

Validation Engineer

Baltimore, MD

... Computer Systems Validation in a biopharmaceutical and biotech environment. Responsibilities * Manage and prioritize all phases of assigned validation projects from concept through performance ...

kindeva

Validation Engineer II

Maryland Heights, MO · On-site

... validation, computer systems validation, and inspection/packaging validation activities. The ... Manager. Responsibilities • Provide validation support across multiple sites based on business ...

kindeva

Validation Engineer II

Maryland Heights, MO · On-site

... validation, computer systems validation, and inspection/packaging validation activities. The ... Manager. Responsibilities • Provide validation support across multiple sites based on business ...

Arcus Biosciences

... Computer Systems Validation (CSV) and lifecycle procedures, and data integrity principles. You will plan, author, implement, and maintain validation for the business and infrastructure systems ...

Deloitte

System Test and Validation Lead

Rosslyn, VA · On-site +1

This role supports system validation strategy, audit readiness, CAPA management, and risk-based ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

Deloitte

System Test and Validation Lead

Midland, MI · On-site +1

This role supports system validation strategy, audit readiness, CAPA management, and risk-based ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

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Computer System Validation Manager information

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$47.5K

$105.4K

$160.5K

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

As of Aug 12, 2026, the average yearly pay for computer system validation manager in the United States is $105,415.00, according to ZipRecruiter salary data. Most workers in this role earn between $74,500.00 and $132,000.00 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.

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What cities are hiring for Computer System Validation Manager jobs? Cities with the most Computer System Validation Manager job openings:
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Computer System Validation Manager jobs near you
Infographic showing various Computer System Validation Manager job openings in the United States as of August 2026, with employment types broken down into 77% Full Time, 6% Part Time, and 17% Contract. Highlights an 83% In-person, 6% Hybrid, and 11% Remote job distribution, with an average salary of $105,415 per year, or $50.7 per hour.

Computer Systems Validation Engineer

Three Point Solutions, Inc.

Maple Grove, MN • On-site

Full-time

Re-posted 10 days ago

Job description

Job title : Computer Systems Validation Engineer-12345
Job Description:
About This Role:
  • To ensure the quality of our client's software applications and equipment by validating/qualifying to specifications.
  • Provide comprehensive documentation (specifications and validation/qualifications) per the division's policy to meet FDA regulations.

Your Responsibilities Include:
  • Define the development of comprehensive specifications (hardware and/or software) for equipment/software from basic functionality to complex systems such as PLC's, Visual Basic applications, databases, SCADA applications, and systems with FDA defined electronic records and electronic signatures.
  • Provide project estimates independently. Review estimates for Engineer I's.
  • Submit specification, protocol and report for approvals and documentation control via a Change Request.
  • Develop comprehensive software validations and/or equipment qualification protocols per the specification.
  • Execute software validation and/or qualification protocols & record results.
  • Document communicate and follow-up on software/equipment issues.
  • Complete project deliverables per project schedule and monitor project schedule and scope changes to assure team can meet delivery requirements.
  • Create documents, links and Change Requests utilizing a Product Data Management system.
  • Provide information on FDA/QSR regulations and internal process validation policy with regards to software validations, equipment installation qualifications, electronic records & signatures.
  • Develop and review comprehensive validation procedures in compliance with FDA.
  • Perform project lead activities on small to large-scale validation/qualification projects. Participate in vendor evaluations.
  • Provide guidance, mentoring and training to Engineer I's & II's. Ensure consistency of work among Engineer I's & II's. Provide peer reviews on specifications, protocols and reports.
  • Influences and defines functional, departmental and divisional policies & procedures through involvement with cross-functional engineering initiatives.
  • Provide leadership role on championing functional best practices.

What We're Looking For:
Minimum Qualifications:
  • Bachelor's Degree in Engineering Discipline
  • 5-9 years direct experience
  • Experience in Medical Device manufacturing specifically writing compliance documentation
  • In depth knowledge of MS Office tools
  • Must have excellent organization, clear verbal and written skills
  • Experience working in a SDLC-system development lifecycle
  • Hand on skills using navigating equipment user interfaces
  • High level attention to detail and ability to support multiple priorities at once
  • Must be team-oriented with people skills and positive can-do attitude in dealing with many customers, from various departments (Engineering, R&D, Manufacturing, Regulatory, etc.)

Preferred Qualifications:
  • Experience working in FDA-regulated industry
  • Experience working with a regulatory body in an audit
  • Performed in a quality role ensuring industry compliance
  • Practical knowledge of 21 CFR Part 11 (electronic records/electronic signature)

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