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Sunrise Systems Inc

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Computer Systems Validation Engineer (MES)_26-02885

Bothell, WA · On-site

$73 - $75/hr

Computer Systems Validation Engineer (MES) Job ID 26-02885 Location: Bothell, WA 98021 Duration: 12 Months Position Type: Hybrid (3 days a week onsite) and required to be onsite throughout UAT ...

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Lonza

Senior IT Validation Engineer

Dover, NH · On-site

Computer Systems Validation Specialist III Location: Portsmouth, NH. Relocation assistance is available for eligible candidates and their families, if needed. The Computer Systems Validation (CSV ...

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Lonza

Senior IT Validation Engineer

Portsmouth, NH · On-site

Computer Systems Validation Specialist III Location: Portsmouth, NH. Relocation assistance is available for eligible candidates and their families, if needed. The Computer Systems Validation (CSV ...

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Lonza

Senior IT Validation Engineer

Kittery, ME · On-site

Computer Systems Validation Specialist III Location: Portsmouth, NH. Relocation assistance is available for eligible candidates and their families, if needed. The Computer Systems Validation (CSV ...

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Computer Systems Validation information

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$10

$54

$86

How much do computer systems validation jobs pay per hour?

As of Jul 1, 2026, the average hourly pay for computer systems validation in the United States is $54.32, according to ZipRecruiter salary data. Most workers in this role earn between $41.83 and $64.42 per hour, depending on experience, location, and employer.

What is the work of computer system validation?

Computer Systems Validation (CSV) is the process of ensuring that computer systems used in regulated environments function correctly and comply with industry standards. It involves documenting and testing software, hardware, and related processes to verify they meet specified requirements, often using validation protocols and tools. CSV helps maintain data integrity, quality, and regulatory compliance in industries like pharmaceuticals and healthcare.

What is the salary of a CSV engineer?

A Computer Systems Validation (CSV) engineer's salary typically ranges from $70,000 to $120,000 annually, depending on experience, location, and industry. Certifications in validation or quality assurance and proficiency with regulatory standards like FDA or GxP can influence compensation levels.

What are the key skills and qualifications needed to thrive in Computer Systems Validation, and why are they important?

To thrive in Computer Systems Validation, you need a solid understanding of regulatory requirements (such as FDA or EMA guidelines), software development life cycles, and risk management, often supported by a degree in life sciences, IT, or engineering. Experience with validation frameworks, documentation tools, and systems like GAMP 5 and knowledge of 21 CFR Part 11 compliance are typically required. Attention to detail, strong analytical thinking, and effective communication set professionals apart in this role. These skills and qualifications ensure validated systems are compliant, reliable, and support organizational quality and regulatory objectives.

Is computer system validation a good field?

Computer Systems Validation (CSV) is a vital role in regulated industries like pharmaceuticals and biotech, ensuring that computer systems meet quality and compliance standards. It involves skills in validation protocols, documentation, and understanding regulatory requirements such as FDA or EMA guidelines. The field offers steady employment opportunities, especially for professionals with certifications like GAMP or 21 CFR Part 11 knowledge.

What is the difference between Computer Systems Validation vs Quality Assurance Specialist?

AspectComputer Systems ValidationQuality Assurance Specialist
CertificationsGAMP, CSV-specific trainingISO 9001, Six Sigma
Work EnvironmentRegulated industries like pharma, biotechManufacturing, software, service sectors
Primary FocusEnsuring computer systems meet regulatory standardsEnsuring overall product/service quality
Common UsageValidation of software, hardware in complianceProcess audits, quality improvement

Computer Systems Validation and Quality Assurance Specialist roles overlap in ensuring compliance and quality. However, CSV focuses specifically on validating computer systems to meet regulatory standards, especially in pharma and biotech industries. Quality Assurance Specialists have a broader scope, overseeing overall quality processes across various sectors. Both roles require similar certifications and work environments but differ in their primary objectives and specific tasks.

What is computer systems validation?

Computer systems validation (CSV) is the process of ensuring that computer-based systems used in regulated industries, like pharmaceuticals and biotechnology, perform their intended functions consistently and reliably. This process involves documenting and testing systems to confirm they meet regulatory requirements, such as those set by the FDA. The goal is to ensure data integrity, product quality, and patient safety by minimizing the risk of system errors or failures. CSV typically includes activities like risk assessment, test planning, execution, and maintaining thorough records for audits.

What is the salary of SoC validation engineer?

The salary of a SoC validation engineer typically ranges from $80,000 to $130,000 annually, depending on experience, location, and company size. Professionals in this role often have skills in hardware description languages and verification tools such as SystemVerilog and UVM.

What are some common challenges faced in a Computer Systems Validation (CSV) role, and how can they be addressed?

Professionals in Computer Systems Validation often encounter challenges such as keeping up with evolving regulatory requirements, managing documentation for multiple systems, and coordinating with cross-functional teams. Staying updated through regular training and industry resources helps address compliance changes. Clear communication and collaboration with IT, Quality Assurance, and business stakeholders are essential for efficient validation processes. Utilizing validation lifecycle management tools and standardized templates can also streamline documentation and reduce errors.
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Computer Systems Validation jobs near you
Infographic showing various Computer Systems Validation job openings in the United States as of June 2026, with employment types broken down into 41% Full Time, and 59% Part Time. Highlights an 91% Physical, 2% Hybrid, and 7% Remote job distribution, with an average salary of $112,983 per year, or $54.3 per hour.
Engineer III, Computer Systems Validation

Engineer III, Computer Systems Validation

Thermo Fisher Scientific

Greenville, NC • On-site

Full-time

Posted 19 hours ago

Thermo Fisher Scientific rating

7.7

Company rating: 7.7 out of 10

Based on 407 frontline employees who took The Breakroom Quiz

190th of 527 rated manufacturers

Job description

Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office
Job Description
As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges.
Description:
Join our validation engineering team as a Validation Engineer III (Computer Systems Validation - CSV), where you will ensure product quality and regulatory compliance across pharmaceutical manufacturing operations.
In this role, you will lead and execute validation activities with a strong focus on automation systems, computerized systems, and change management for existing commercial manufacturing lines. You will evaluate system and process changes, determine validation impact, and drive qualification strategies to ensure compliance with cGMP requirements.
You will collaborate cross-functionally with automation, manufacturing, and quality teams while serving as a technical resource during regulatory inspections and client audits. This role requires a high level of independence, technical expertise, and the ability to lead complex validation efforts.
A Day in the Role:
  • Lead validation activities for equipment, processes, utilities, and computer systems, with emphasis on CSV
  • Evaluate and support change management for existing manufacturing systems and automation platforms
  • Author, review, and execute validation documentation including IQ/OQ/PQ protocols and qualification plans
  • Perform and lead risk assessments, gap analyses, and validation assessments
  • Collaborate with automation engineers on systems such as PLC, SCADA, DCS, DeltaV, and Allen-Bradley platforms
  • Independently manage validation projects and coordinate cross-functional teams
  • Provide technical expertise during regulatory inspections and client audits
  • Mentor junior team members and support knowledge sharing across the team
  • Contribute to continuous improvement and operational excellence initiatives

Requirements:
  • Bachelor's degree in Engineering, Life Sciences, Chemistry, or related technical field

Equivalency:
Equivalent combinations of education, training, and relevant experience may be considered in place of a degree
  • Minimum of 4 years of validation experience in pharmaceutical/biotech manufacturing or comparable regulated industry
  • Strong knowledge of cGMP regulations (FDA, EMA, ISO)
  • Experience with Computer Systems Validation (CSV), CQV, or automation validation
  • Experience writing and executing IQ/OQ/PQ validation protocols
  • Experience with automation and control systems (PLC, SCADA, DCS, DeltaV, Allen-Bradley)
  • Proven ability to lead validation projects and work cross-functionally
  • Strong technical writing and documentation skills
  • Experience with risk assessment methodologies and statistical analysis
  • Advanced problem-solving and root cause analysis skills
  • Excellent verbal and written communication skills
  • Proficiency with MS Office and validation-related systems

Preferred:
  • Experience supporting or contributing to capital (CapEx) projects
  • Experience with regulatory inspections and client audits
  • Knowledge of lean manufacturing and continuous improvement methodologies

Additional Information:
  • Ability to work in cleanroom environments as required
  • Flexibility to support extended hours or off-shift work during project activities or shutdowns
  • May require up to 25% travel

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