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Gxp Computer Validation Jobs (NOW HIRING)

CAI

Computer Systems Validation Engineer

Baltimore, MD · On-site

$75K - $106K/yr

... GxP computer validation documentation (e.g., URS, FRS, RTM, summary reports) Generate and execute test protocols and scripts Ensure adherence to 21 CFR Part 11 and data integrity principles Review ...

CAI

Computer Systems Validation Engineer

Rockville, MD

$75K - $106K/yr

... GxP computer validation documentation (e.g., URS, FRS, RTM, summary reports) Generate and execute test protocols and scripts Ensure adherence to 21 CFR Part 11 and data integrity principles Review ...

CAI

Computer Systems Validation Engineer

Baltimore, MD

$75K - $106K/yr

... GxP computer validation documentation (e.g., URS, FRS, RTM, summary reports) Generate and execute test protocols and scripts Ensure adherence to 21 CFR Part 11 and data integrity principles Review ...

CAI

Computer Systems Validation Engineer

Rockville, MD · On-site

$75K - $106K/yr

... GxP computer validation documentation (e.g., URS, FRS, RTM, summary reports) Generate and execute test protocols and scripts Ensure adherence to 21 CFR Part 11 and data integrity principles Review ...

CAI

Computer Systems Validation Engineer

Boston, MA · On-site

$75K - $106K/yr

... GxP computer validation documentation (e.g., URS, FRS, RTM, summary reports) Generate and execute test protocols and scripts Ensure adherence to 21 CFR Part 11 and data integrity principles Review ...

CAI

Computer Systems Validation Engineer

Indianapolis, IN · On-site

$75K - $106K/yr

... GxP computer validation documentation (e.g., URS, FRS, RTM, summary reports) Generate and execute test protocols and scripts Ensure adherence to 21 CFR Part 11 and data integrity principles Review ...

CAI

Computer Systems Validation Engineer

Baltimore, MD · On-site

$75K - $106K/yr

... GxP computer validation documentation (e.g., URS, FRS, RTM, summary reports) Generate and execute test protocols and scripts Ensure adherence to 21 CFR Part 11 and data integrity principles Review ...

CAI

Computer Systems Validation Engineer

Indianapolis, IN · On-site

$75K - $106K/yr

... GxP computer validation documentation (e.g., URS, FRS, RTM, summary reports) Generate and execute test protocols and scripts Ensure adherence to 21 CFR Part 11 and data integrity principles Review ...

CAI

Computer Systems Validation Engineer

Boston, MA · On-site

$75K - $106K/yr

... GxP computer validation documentation (e.g., URS, FRS, RTM, summary reports) Generate and execute test protocols and scripts Ensure adherence to 21 CFR Part 11 and data integrity principles Review ...

CAI

Computer Systems Validation Engineer

Indianapolis, IN · On-site

$75K - $106K/yr

... GxP computer validation documentation (e.g., URS, FRS, RTM, summary reports) Generate and execute test protocols and scripts Ensure adherence to 21 CFR Part 11 and data integrity principles Review ...

CAI

Computer Systems Validation Engineer

Boston, MA · On-site

$75K - $106K/yr

... GxP computer validation documentation (e.g., URS, FRS, RTM, summary reports) Generate and execute test protocols and scripts Ensure adherence to 21 CFR Part 11 and data integrity principles Review ...

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Gxp Computer Validation information

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$86

How much do gxp computer validation jobs pay per hour?

As of Sep 9, 2026, the average hourly pay for gxp computer 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 GxP computer validation?

GxP computer validation is the process of ensuring that computerized systems used in regulated industries, such as pharmaceuticals and biotechnology, comply with Good Practice (GxP) guidelines. This involves rigorous documentation, testing, and verification to confirm that the systems operate as intended and maintain data integrity, security, and traceability. GxP validation is critical for meeting regulatory requirements set by agencies like the FDA and EMA, helping to ensure product quality and patient safety.

What are some common challenges faced by GxP computer validation specialists, and how can they be addressed?

GxP Computer Validation specialists often encounter challenges such as keeping up with evolving regulatory requirements, managing documentation for audits, and ensuring systems remain compliant throughout their lifecycle. Addressing these challenges typically involves continuous professional development to stay current with industry standards, implementing robust validation protocols, and fostering close collaboration with IT, QA, and business teams. Proactive communication and thorough documentation are key to streamlining audits and maintaining compliance.

What are the key skills and qualifications needed to thrive as a GxP computer validation specialist, and why are they important?

To thrive as a GxP Computer Validation Specialist, you need a solid understanding of regulatory compliance, quality assurance, and computer system validation principles, typically supported by a degree in life sciences, engineering, or a related field. Familiarity with validation tools, 21 CFR Part 11, GAMP 5 guidelines, and systems like LIMS or ERP is crucial, along with relevant certifications such as CSV or PMP. Attention to detail, problem-solving skills, and effective communication are vital soft skills for ensuring documentation accuracy and collaborating with cross-functional teams. Mastery of these skills ensures validated systems meet regulatory requirements, maintain data integrity, and support safe and efficient operations in regulated environments.

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

AspectGxp Computer ValidationGxp Quality Assurance Specialist
CertificationsGxP validation training, GMP/GLP/GCP knowledgeGxP compliance, GMP/GLP/GCP certifications
Work EnvironmentValidation labs, manufacturing facilitiesQuality departments, regulatory offices
Industry UsagePharmaceutical, biotech, medical devicePharmaceutical, biotech, medical device

Gxp Computer Validation focuses on ensuring computer systems meet regulatory standards through validation processes, while Gxp Quality Assurance Specialists oversee overall quality compliance and audits. Both roles require GxP knowledge and often collaborate but serve different functions within the industry.

What other helpful pages are available for Gxp Computer Validation?

Other pages related to Gxp Computer Validation:

Infographic showing various Gxp Computer Validation job openings in the United States as of September 2026, with employment types broken down into 1% Internship, 1% As Needed, 82% Full Time, 13% Part Time, 2% Contract, and 1% Nights. Highlights an 81% Physical, 1% Hybrid, and 18% Remote job distribution, with an average salary of $112,983 per year, or $54.3 per hour.

Manager, Computer Systems Validation (CSV)

Redwood City, CA • On-site

Corcept Therapeutics
Biotechnology Research and Development • 51 - 200 employees
Learn more about Corcept Therapeuticsexternal

$160K - $189K/yr

Full-time

Re-posted 6 days ago

Job description

The Manager, Computer Systems Validation (CSV) will be a core member of the Quality Systems Technology team and responsible for the implementation, management, ongoing support and review of Corcept's internal GXP validated systems. This individual will ensure IT Quality and Risk Management standards are defined, understood, designed into work activity, and achieved. This position will manage day-to-day operations for IT Compliance and Risk Management, working closely with key stakeholders from business teams, particularly QA, heavily guiding business teams on validation principles and requirements throughout the system lifecycle. This role will ensure compliance risks are identified, mitigated, and managed appropriately.

Responsibilities:

  • Provide assessment/review/oversight for Enterprise / GXP computer systems validation (focus on Pharmaceutical Systems)  
  • Experienced in developing validation strategies and authoring validation documents such as validation master plans, data migration plans, protocols, reports, discrepancies    
  • Ensure compliance and the validated state of all GXP systems 
  • Provide validation guidance on data migration activities as needed
  • Provide IT assessment and approval for GXP computer system changes
  •  Develop and support testing of proposed changes in system development environments
  • Experience in authoring and managing documents such as change control, Risk Assessments, Validation Plans, User Requirements Specifications, Functional Specifications, qualification protocols (IQ/OQ/PQ), Traceability Matrix, system procedures, deviations and CAPAs
  • Coordinate and support vendor support release activities 
  • Support and provide guidance to cross-functional groups with GXP system implementation projects and ongoing validation needs including system enhancements, releases and revalidation
  • Responsible to manage external CSV consultants in CSV projects 
  • Responsible as interface between IT and QA 

Preferred Education and Experience:

  • 8+ years' experience in QA or Validation performing protocol review and approval associated with the implementation and maintenance of computerized systems in pharma/biotech environment 
  • Solid knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 210, 211& 11, Annex 11, GAMP5, ICH Q9, Data Integrity, CSA 

Skills, Qualifications, or Technical Proficiencies:

  • Thorough understanding of validation/qualification and concepts as it applies to pharmaceutical quality systems 
  • Excellent communication skills with the ability to effectively communicate across organizational levels and functions 
  • Proficiency with Veeva QualityDocs / QMS and ComplianceWire 
  • Experience with CTMS and Regulatory systems  
  • Ability to manage external software and consultant vendors 

The pay range that the Company reasonably expects to pay for this headquarters-based position is $160,600 - $189,000; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

 Applicants must be currently authorized to work in the United States on a full-time basis.

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