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Computer System Validation Manager Jobs (NOW HIRING)

Supermicro

System Validation Engineer

San Jose, CA · On-site

$100K - $113K/yr

Supermicro Computer is currently looking for talented System Validation Engineer to partner with ... Work with customers and product management to understand production use of the product and ...

CAI

Computer Systems Validation Engineer

Indianapolis, IN · 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 ...

CAI

Computer Systems Validation Engineer

Rockville, MD

$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 ...

CAI

Computer Systems Validation Engineer

Indianapolis, IN · 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 ...

Lyte

System Validation Engineer

Sunnyvale, CA · On-site

$130K - $230K/yr

... management ICs. Your core strength: methodically isolating problems and localizing them to a ... Lead PCB and system-level bringup, first power-on through functional validation * Isolate failures ...

CAI

Computer Systems Validation Engineer

Rockville, 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 ...

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 ...

Micron

System Validation Technician

Boise, ID · On-site

Associate degree (AAS) in Electronics, Computer Science, IT, or a related field (or equivalent ... At least 1 year of experience using ticketing or workflow management tools (e.g., Jira, ServiceNow ...

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 ...

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 ...

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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.

More about Computer System Validation Manager jobs
What cities are hiring for Computer System Validation Manager jobs? Cities with the most Computer System Validation Manager job openings:
What are the most commonly searched types of Computer System Validation jobs? The most popular types of Computer System Validation jobs are:
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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.

Sr. Manager QA Validation Computerization Systems

Lynkx Staffing LLC

Saddle Brook, NJ

Full-time

Re-posted 24 days ago

Job description

Sr. Manager Quality Assurance Validation Computerization Systems The incumbent will be responsible for supporting the Computerized System project teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. Will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving.
  • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements.
  • Contributes expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments.
  • Develops and evaluates quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements.
  • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications.
  • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports.
  • Coordinate implementation validation/qualification strategies and serve as the subject matter expert.
  • Present project status reports to management as well as project teams.
  • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes.
  • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements.
  • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report.
  • Support internal, client, and regulatory audits and inspections.
  • Generate or review/update computer system related policies, procedures, templates, forms, etc.
  • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures.
  • Performs other quality system related duties as necessary.
REQUIREMENTS
  • Bachelor’s Degree in a Scientific or Engineering discipline
  • 8 + years of computerized system experience with IT compliance/validation/qualification activities.
  • 8 + years of experience working in an FDA-regulated, GxP-related environment.
  • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance.
  • Comprehensive knowledge in Software Validation and Data Integrity Principles.
  • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations.
  • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models.
  • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems.
  • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ).
  • Knowledge of Software Risk Management Principles and tools.
  • Knowledge and proven ability working with Risk Management methodologies and tools.
  • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus.
  • Experience with application system validation and infrastructure qualification.
  • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus.
  • Experience with writing and approving Standard Operating Procedures and Quality Standards.
  • 10% travel required.
  • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint).
  • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams.
  • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers.
  • Solid organizational and time management skills, proven project management, presentation and facilitation skills.
  • Innovation and strategic compliance skills including looking internally and externally for best practices.
  • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems.
  • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities.
  • The ability to enable and drive change while being focused on internal and external customers.
  • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines.
  • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.