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Computer System Validation Engineer Jobs (NOW HIRING)

Validation Engineer The Validation Engineer manages and prioritizes all phases of assigned ... Contribute subject matter expertise in Commissioning and Qualification and Computer Systems ...

WI · On-site

$110 - $140/hr

Position Summary We are seeking an experienced Senior Computer System Validation (CSV) Engineer to support validation activities for GMP-regulated manufacturing and automation systems at client. The ...

Senior System Validation Engineer

San Jose, CA · Hybrid

$122K - $167K/yr

S. in Computer Engineering, Electrical Engineering, or related field. * 5+ years of experience in system validation, memory interfaces, or related semiconductor work. * Must have expertise in high ...

Senior System Validation Engineer

Johns Creek, GA · Hybrid

$96K - $132K/yr

S. in Computer Engineering, Electrical Engineering, or related field. * 5+ years of experience in system validation, memory interfaces, or related semiconductor work. * Must have expertise in high ...

We have an opportunity for a forward-thinking and especially hardworking system validation engineer with strong background in high speed serial links. As a member of our dynamic team, you will have ...

We have an opportunity for a forward-thinking and especially hardworking system validation engineer with strong background in high speed serial links. As a member of our dynamic team, you will have ...

We have an opportunity for a forward-thinking and especially hardworking system validation engineer with strong background in high speed serial links. As a member of our dynamic team, you will have ...

... computer validation documentation (e.g., URS, FRS, RTM, summary reports) Generate and execute test ... System & Industry Expertise Support CSV activities across various platforms including MES, DCS ...

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Computer System Validation Engineer information

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How much do computer system validation engineer jobs pay per hour?

As of Aug 15, 2026, the average hourly pay for computer system validation engineer in the United States is $51.80, according to ZipRecruiter salary data. Most workers in this role earn between $38.94 and $64.42 per hour, depending on experience, location, and employer.

What are some common challenges faced by computer system validation engineers in regulated industries?

Computer System Validation Engineers often encounter challenges such as keeping up with evolving regulatory requirements, managing documentation for multiple systems, and ensuring timely validation while coordinating with cross-functional teams. Balancing strict compliance with project deadlines can be demanding, especially when systems are complex or legacy infrastructure is involved. Additionally, effective communication with IT, QA, and business stakeholders is essential to address issues quickly and maintain validation standards.

Are computer system validation engineers in demand?

Computer System Validation Engineers are in demand due to the increasing regulation of pharmaceutical, biotech, and medical device industries that require compliant validation of computer systems. They often need skills in validation protocols, GxP regulations, and validation tools, making their expertise valuable in ensuring quality and compliance in regulated environments.

What does a computer system validation engineer do?

A computer system validation engineer ensures that computer systems used in regulated industries, such as pharmaceuticals or biotech, meet required standards for quality and compliance. They develop validation protocols, execute testing, and document results to verify systems function correctly and consistently. This role often involves working with validation tools, regulatory guidelines, and maintaining detailed records to support audits and inspections.

What are the key skills and qualifications needed to thrive as a computer system validation engineer?

To thrive as a Computer System Validation Engineer, you need a solid background in computer science or engineering, knowledge of regulatory requirements (such as FDA or GxP), and experience in validation processes. Familiarity with validation tools, quality management systems, and documentation software is typically required, along with certifications like ISPE or ASQ being beneficial. Strong attention to detail, analytical thinking, and effective communication are essential soft skills for coordinating teams and ensuring compliance. These skills and qualities are crucial to ensure that computer systems meet regulatory standards, maintain data integrity, and support business operations in regulated industries.

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

AspectComputer System Validation EngineerQuality Assurance Specialist
CertificationsGAMP, GxP validation certificationsISO, Six Sigma, GMP certifications
Work EnvironmentPharmaceutical, biotech, medical device industriesManufacturing, software, healthcare sectors
Primary FocusValidating computer systems and software complianceEnsuring overall quality and process improvements

The Computer System Validation Engineer primarily focuses on validating computer systems to meet regulatory standards, ensuring software compliance in regulated industries. In contrast, the Quality Assurance Specialist oversees broader quality processes, including audits and process improvements. Both roles require knowledge of industry regulations but differ in scope and specific responsibilities.

Do computer system validation engineers make good money?

Computer System Validation Engineers typically earn competitive salaries that vary by experience, location, and industry. They often have specialized skills in validation protocols, regulatory compliance, and validation tools, which can contribute to higher earning potential. Overall, this role is considered well-compensated within the pharmaceutical, biotech, and healthcare sectors.

Is computer system validation a good field?

Computer System Validation (CSV) is a vital part of regulated industries like pharmaceuticals and biotech, ensuring that computer systems meet quality and compliance standards. It offers opportunities for roles such as validation engineers, often requiring knowledge of GxP regulations, validation protocols, and tools like audit trails. The field provides stable employment with potential for career growth, especially with certifications like GAMP or 21 CFR Part 11 knowledge.
More about Computer System Validation Engineer jobs

What cities are hiring for Computer System Validation Engineer jobs?

Cities with the most Computer System Validation Engineer job openings:

What states have the most Computer System Validation Engineer jobs?

States with the most job openings for Computer System Validation Engineer jobs include:

Infographic showing various Computer System Validation Engineer job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 84% Full Time, 12% Part Time, and 3% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $107,747 per year, or $51.8 per hour.

Computer Systems Validation Engineer

Lonza

Portsmouth, NH

Full-time

Re-posted 12 days ago


Lonza rating

8.3

Company rating: 8.3 out of 10

Based on 42 frontline employees who took The Breakroom Quiz

25th of 86 rated pharmaceutical


Job description

Computer Systems Validation Engineer

Location:Portsmouth, NH. Relocation assistance is available for eligible candidates and their families, if needed.

The Computer Systems Validation (CSV) Engineer will, as an individual contributor, identify and implement industry best practices through an extensive industry network and detailed knowledge of applicable regulations. During the scoping portion of these improvement projects the person in this role will work with other experienced members of the CSV team to identify roadblocks and additional efficiencies. Additional day to day tasks will include risk assessing systems, reviewing change requests and test scripts, drafting protocols and initiating and reviewing GMP documentation revisions.

What you will get:

  • Competitive salary and comprehensive benefits package.

  • Opportunities for career development and advancement.

  • Supportive and collaborative team environment.

  • Access to cutting-edge technology and tools.

  • Commitment to employee well-being and safety.

  • Inclusive workplace culture.

  • Recognition and reward for your contributions.

Access to our full list of global benefits:https://www.lonza.com/careers/benefits

What you will do:

  • Lead efforts between internal customers and CSV to ensure assigned activities are prioritized, communicated in an effective and timely manner, and completed on time.

  • Accountable for maintaining full knowledge of Lonza's policies/procedures, 21 CFR Part 11, Data Integrity, ICH Q7A requirements and GAMP and the underlying principles of each.

  • Perform all aspects of Quality Systems Management (QSM) processes (Change Control, Deviation, Corrective and Preventable Actions) as well as Validation Maintenance of computerized systems.

  • Participate in audits and inspections as a Subject Matter Expert.

  • Own, revise and maintain computer systems validation SOPs (Standard Operations Procedures).

  • Function as CSV SME in Inspections and Audits.

  • Mentor and train junior members of the department.

What we are looking for:

  • Bachelor's degree required, preferred in computer science, engineering, or other sciences.

  • Minimum of 5 years of experience working with automation and/or computerized system validations.

  • Minimum 2 years' experience with Controls Automation, Process Control Systems, Distributed Systems, Manufacturing Execution Systems (MES) required, DeltaV preferred.

  • Prior experience leading or managing projects beneficial.

  • CAPAs and deviations experience desired.

  • Biotech/Pharma/Medical Device/Medical or biologics industry experience required.

  • Ability to work independently and meet deadlines successfully.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone's ideas, big or small, have the potential to improve millions of lives, and that's the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you're ready to help turn our customers' breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Ready to shape the future of life sciences? Apply now.


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