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Computer Systems Validation Specialist Jobs (NOW HIRING)

Lupin

Computer Systems Validation Engineer

Somerset, NJ · On-site

... Computer Software Assurance) and GAMP 5 principles. Support validation activities in GMP laboratory and manufacturing systems, including system implementation, upgrades, and remediation. Work on ...

New

CAI

Computer Systems Validation Engineer

Baltimore, MD · On-site

$75K - $106K/yr

... computer systems validation Experience in biotech or pharmaceutical environments preferred over medical device In-depth understanding of GAMP guidelines and FDA regulations (21 CFR 11, 210, 211 ...

CAI

Computer Systems Validation Engineer

Indianapolis, IN · On-site

$75K - $106K/yr

... computer systems validation Experience in biotech or pharmaceutical environments preferred over medical device In-depth understanding of GAMP guidelines and FDA regulations (21 CFR 11, 210, 211 ...

CAI

Computer Systems Validation Engineer

Indianapolis, IN · On-site

$75K - $106K/yr

... computer systems validation Experience in biotech or pharmaceutical environments preferred over medical device In-depth understanding of GAMP guidelines and FDA regulations (21 CFR 11, 210, 211 ...

CAI

Computer Systems Validation Engineer

Boston, MA · On-site

$75K - $106K/yr

... computer systems validation Experience in biotech or pharmaceutical environments preferred over medical device In-depth understanding of GAMP guidelines and FDA regulations (21 CFR 11, 210, 211 ...

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Computer Systems Validation Specialist information

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How much do computer systems validation specialist jobs pay per hour?

As of Sep 11, 2026, the average hourly pay for computer systems validation specialist 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 a computer systems validation specialist?

Computer Systems Validation Specialists are professionals responsible for ensuring that computer systems used in regulated industries, such as pharmaceuticals or medical devices, meet all required standards for quality, compliance, and functionality. They develop and execute validation protocols, document testing procedures, and verify that systems consistently produce results that meet predetermined specifications. Their work is essential for meeting regulatory guidelines such as those set by the FDA, EMA, or other governing bodies, helping organizations avoid costly compliance issues and ensuring patient safety.

What are the key skills and qualifications needed to thrive as a computer systems validation specialist?

To thrive as a Computer Systems Validation Specialist, you need a solid background in computer science, information technology, or a related field, often supported by a relevant degree and experience with regulatory compliance in industries like pharmaceuticals or healthcare. Familiarity with validation tools, documentation management systems, and regulations such as FDA 21 CFR Part 11 or GAMP 5 is typically required, and certifications like CSV Professional (CSV-P) can be advantageous. Strong attention to detail, problem-solving abilities, and effective communication are crucial soft skills for ensuring thorough validation and collaboration with cross-functional teams. These skills and qualifications are vital to ensure that computer systems meet regulatory standards, maintain data integrity, and support quality assurance in regulated environments.

What are some common challenges faced by computer systems validation specialists when working with cross-functional teams?

Computer Systems Validation Specialists often collaborate with IT, Quality Assurance, and end-users to ensure systems meet regulatory requirements. A common challenge is aligning the diverse expectations and communication styles among these groups, especially when interpreting compliance standards. Specialists must facilitate clear documentation, manage timelines, and address technical misunderstandings, all while ensuring validation deliverables are met. Building strong working relationships and proactively addressing issues helps streamline project progress and maintain compliance.

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

AspectComputer Systems Validation SpecialistQuality Assurance Specialist
CertificationsGxP, 21 CFR Part 11, CSV-specific trainingISO 9001, Six Sigma, QA certifications
Work EnvironmentPharmaceutical, biotech, regulated industriesManufacturing, software, healthcare sectors
Primary FocusValidating computer systems to ensure complianceEnsuring product and process quality
Common UsageRegulatory compliance, validation projectsProcess improvement, defect prevention

While both roles aim to ensure quality and compliance, the Computer Systems Validation Specialist primarily focuses on validating computer systems to meet regulatory standards, especially in pharma and biotech industries. The Quality Assurance Specialist has a broader scope, overseeing overall product and process quality across various sectors. Both roles require similar certifications and work in regulated environments, but their core responsibilities differ in scope and focus.

Who are the top companies hiring for Computer Systems Validation Specialist jobs?

The top employers for Computer Systems Validation Specialist jobs are:

What states have the most Computer Systems Validation Specialist jobs?

States with the most job openings for Computer Systems Validation Specialist jobs include:

What are popular job titles related to Computer Systems Validation Specialist jobs?

For Computer Systems Validation Specialist jobs, the most frequently searched job titles are:

Computer Systems Validation Specialist jobs near you
Infographic showing various Computer Systems Validation Specialist job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 85% Full Time, 9% Part Time, 4% Contract, and 1% Nights. Highlights an 88% Physical, 3% Hybrid, and 9% Remote job distribution, with an average salary of $112,983 per year, or $54.3 per hour.

Computer Systems Validation Engineer

Portsmouth, NH • On-site

Lonza
Biotechnology Research and Development • 10K+ employees
Learn more about Lonzaexternal

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Re-posted 10 days ago

Lonza rating

8.3

Company rating: 8.3 out of 10

Based on 42 frontline employees who took The Breakroom Quiz

Job description

Computer Systems Validation Engineer

United States, Portsmouth (New Hampshire)

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.
Responsibilities
  • 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 Preventive 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 Operating Procedures).
  • Function as CSV SME in Inspections and Audits.
  • Mentor and train junior members of the department.
Qualifications
  • 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.

Equal employment opportunities are available 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.

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About Lonza

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Industry

Biotechnology research and development and pharmaceutical and medicine manufacturing

Company size

10,000+ Employees

Headquarters location

Bern, KS, US

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