The role involves leading end-to-end Computer System Validation activities, ensuring compliance with regulations and quality procedures in regulated environments. Responsibilities : • Lead and ...
The role involves leading end-to-end Computer System Validation activities, ensuring compliance with regulations and quality procedures in regulated environments. Responsibilities : • Lead and ...
Computer System Validation Lead
Wilmington, DE · On-site
$100K - $120K/yr
Must Have Technical/Functional Skill • 810 years of experience in Computer System Validation (CSV) in regulated (GxP) environments (Pharma / Biotech / MedTech). • Hands-on experience with ...
Computer System Validation Lead
Wilmington, DE · On-site
$100K - $120K/yr
Must Have Technical/Functional Skill • 810 years of experience in Computer System Validation (CSV) in regulated (GxP) environments (Pharma / Biotech / MedTech). • Hands-on experience with ...
COMPUTER SYSTEM VALIDATION LEAD Wilmington, DE Fulltime 10+ years of experience Must Have Technical/Functional Skill • 8-10 years of experience in Computer System Validation (CSV) in regulated ...
New
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COMPUTER SYSTEM VALIDATION LEAD Wilmington, DE Fulltime 10+ years of experience Must Have Technical/Functional Skill • 8-10 years of experience in Computer System Validation (CSV) in regulated ...
New
Associate Director, QA Computer System Validation
Radnor, PA · On-site
$184K - $215K/yr
Reporting to the Director, QA Computer System Validation (CSV), the Associate Director, CSV is responsible for compliance oversight of computer system validation projects as part of the quality ...
Associate Director, QA Computer System Validation
Radnor, PA · On-site
$184K - $215K/yr
Reporting to the Director, QA Computer System Validation (CSV), the Associate Director, CSV is responsible for compliance oversight of computer system validation projects as part of the quality ...
Associate Director, QA Computer System Validation
Radnor, PA · Hybrid
$184K - $215K/yr
Reporting to the Director, QA Computer System Validation (CSV), the Associate Director, CSV is responsible for compliance oversight of computer system validation projects as part of the quality ...
Associate Director, QA Computer System Validation
Radnor, PA · Hybrid
$184K - $215K/yr
Reporting to the Director, QA Computer System Validation (CSV), the Associate Director, CSV is responsible for compliance oversight of computer system validation projects as part of the quality ...
Computer validation Engineer
$107K - $127K/yr
Execute Computer System validation (CSV) protocols. Write and resolve protocol deviations. Write ... test summary reports. Prior Wonderware, Allen Bradley, field wiring experience is a plus. Candidate ...
Computer validation Engineer
$107K - $127K/yr
Execute Computer System validation (CSV) protocols. Write and resolve protocol deviations. Write ... test summary reports. Prior Wonderware, Allen Bradley, field wiring experience is a plus. Candidate ...
CSV Lead/ Computer System Validation Lead
Philadelphia, PA · On-site
$97K - $129K/yr
CSV Lead/ Computer System Validation Lead Location : Marietta, PA Compli, LLC was founded in 2001 to provide Commissioning, Validation and Regulatory Support Services to the Life Sciences industry.
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CSV Lead/ Computer System Validation Lead
Philadelphia, PA · On-site
$97K - $129K/yr
CSV Lead/ Computer System Validation Lead Location : Marietta, PA Compli, LLC was founded in 2001 to provide Commissioning, Validation and Regulatory Support Services to the Life Sciences industry.
CSV Lead/ Computer System Validation Lead Location : Marietta, PA Compli, LLC was founded in 2001 to provide Commissioning, Validation and Regulatory Support Services to the Life Sciences industry.
CSV Lead/ Computer System Validation Lead Location : Marietta, PA Compli, LLC was founded in 2001 to provide Commissioning, Validation and Regulatory Support Services to the Life Sciences industry.
This role will be responsible for understanding modern computer systems and control/digital systems within the facility. It is important for the individual to have a background that will enable ...
This role will be responsible for understanding modern computer systems and control/digital systems within the facility. It is important for the individual to have a background that will enable ...
Drive Computer System Validation (CSV) and Computer Software Assurance (CSA) activities * Author, review, and manage validation documentation using Kneat or equivalent digital validation platforms
Drive Computer System Validation (CSV) and Computer Software Assurance (CSA) activities * Author, review, and manage validation documentation using Kneat or equivalent digital validation platforms
Senior Validation Engineer
King Of Prussia, PA · On-site +1
Development of procedures, practices, and policies related to computer system validation.Monitor and update the Validation Master Plan to ensure that it complies with appropriate regulatory ...
Senior Validation Engineer
King Of Prussia, PA · On-site +1
Development of procedures, practices, and policies related to computer system validation.Monitor and update the Validation Master Plan to ensure that it complies with appropriate regulatory ...
Digital Systems Validation Lead
Wayne, PA · On-site
$116K - $130K/yr
Master's degree preferred * 8+ years of experience in computer system validation within regulated industries such as healthcare, pharmaceutical, medical device, or life sciences * Strong knowledge of ...
Digital Systems Validation Lead
Wayne, PA · On-site
$116K - $130K/yr
Master's degree preferred * 8+ years of experience in computer system validation within regulated industries such as healthcare, pharmaceutical, medical device, or life sciences * Strong knowledge of ...
Digital Systems Validation Lead
Wayne, PA · On-site
$116K - $130K/yr
Master's degree preferred * 8+ years of experience in computer system validation within regulated industries such as healthcare, pharmaceutical, medical device, or life sciences * Strong knowledge of ...
Digital Systems Validation Lead
Wayne, PA · On-site
$116K - $130K/yr
Master's degree preferred * 8+ years of experience in computer system validation within regulated industries such as healthcare, pharmaceutical, medical device, or life sciences * Strong knowledge of ...
Digital Systems Validation Lead
Wayne, PA · Hybrid
$116K - $130K/yr
Master's degree preferred * 8+ years of experience in computer system validation within regulated industries such as healthcare, pharmaceutical, medical device, or life sciences * Strong knowledge of ...
Digital Systems Validation Lead
Wayne, PA · Hybrid
$116K - $130K/yr
Master's degree preferred * 8+ years of experience in computer system validation within regulated industries such as healthcare, pharmaceutical, medical device, or life sciences * Strong knowledge of ...
System Assurance Lead
Philadelphia, PA · On-site
Primary Skill- Computer System Validation, Computer system assurance, GAMP, GxP risk assessments, Change Management, Communication, and Organization. Secondary Skill- JIRA, Veeva , Agile, and ...
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System Assurance Lead
Philadelphia, PA · On-site
Primary Skill- Computer System Validation, Computer system assurance, GAMP, GxP risk assessments, Change Management, Communication, and Organization. Secondary Skill- JIRA, Veeva , Agile, and ...
6420 - Senior CSV Engineer / Senior Validation Engineer
King Of Prussia, PA · Remote
$104K - $142K/yr
... Computer System Validation (CSV) / Computer System Assurance within regulated life sciences * Demonstrated leadership of validation strategy, lifecycle deliverables, and SDLC compliance * Strong ...
6420 - Senior CSV Engineer / Senior Validation Engineer
King Of Prussia, PA · Remote
$104K - $142K/yr
... Computer System Validation (CSV) / Computer System Assurance within regulated life sciences * Demonstrated leadership of validation strategy, lifecycle deliverables, and SDLC compliance * Strong ...
System Assurance Lead
King Of Prussia, PA · On-site
Primary Skill- Computer System Validation, computed system assurance, GAMP, GxP risk assessments, Change Management Secondary Skill- JIRA Veeva Argus Agile and Waterfall methodology 10+ years ...
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System Assurance Lead
King Of Prussia, PA · On-site
Primary Skill- Computer System Validation, computed system assurance, GAMP, GxP risk assessments, Change Management Secondary Skill- JIRA Veeva Argus Agile and Waterfall methodology 10+ years ...
Experience with SCADA, MES, and database systems, or computer system validation are considered a plus.
Experience with SCADA, MES, and database systems, or computer system validation are considered a plus.
Bachelor's degree in Computer Science, Engineering, Information Systems, Life Sciences, or related discipline. * 8+ years of Computer System Validation (CSV), CSA, or IT Compliance experience within ...
Bachelor's degree in Computer Science, Engineering, Information Systems, Life Sciences, or related discipline. * 8+ years of Computer System Validation (CSV), CSA, or IT Compliance experience within ...
(Sr.) Validation Engineer
$80K - $120K/yr
Support facility, utility, equipment, process, cleaning, and computer system validation (CSV) activities. * Support technology transfer and startup activities for new client manufacturing programs.
(Sr.) Validation Engineer
$80K - $120K/yr
Support facility, utility, equipment, process, cleaning, and computer system validation (CSV) activities. * Support technology transfer and startup activities for new client manufacturing programs.
Computer System Validation information
See Philadelphia, PA salary details
$10.11 - $16.67
2% of jobs
$16.67 - $23.22
9% of jobs
$23.22 - $29.78
1% of jobs
$29.78 - $36.34
4% of jobs
$40.32 is the 25th percentile. Wages below this are outliers.
$36.34 - $42.90
15% of jobs
$42.90 - $49.46
9% of jobs
The median wage is $54.92 / hr.
$49.46 - $56.02
13% of jobs
$61.24 is the 75th percentile. Wages above this are outliers.
$56.02 - $62.57
29% of jobs
$62.57 - $69.13
12% of jobs
$69.13 - $75.69
2% of jobs
$75.69 - $82.25
5% of jobs
$10
$51
$82
How much do computer system validation jobs pay per hour?
What are some typical challenges faced in Computer System Validation roles?
Professionals in Computer System Validation often encounter challenges such as keeping up with evolving regulatory requirements, ensuring complete and accurate documentation, and coordinating with cross-functional teams to implement validation protocols. Balancing thoroughness with project deadlines can also be demanding, as every validation step must stand up to external audits. However, these challenges provide valuable experience, strengthen project management abilities, and emphasize teamwork—key attributes that support career advancement into validation leadership or quality assurance roles.
What is a Computer System Validation job?
A Computer System Validation (CSV) job involves ensuring that computer systems used in regulated industries, such as pharmaceuticals and medical devices, meet compliance and regulatory requirements. CSV professionals develop and execute validation protocols to confirm that software, hardware, and processes function as intended and maintain data integrity. They work with quality assurance, IT, and regulatory teams to document compliance with standards like FDA 21 CFR Part 11 and GxP. This role is critical in maintaining system reliability, product quality, and patient safety.
What are the key skills and qualifications needed to thrive in the Computer System Validation position, and why are they important?
To excel in Computer System Validation, candidates typically need a background in computer science, engineering, or life sciences, with expertise in validating software and systems in regulated environments such as pharmaceuticals or medical devices. Familiarity with tools like validation documentation software, GAMP 5 guidelines, FDA 21 CFR Part 11 regulations, and potentially certifications like CSV Professional or Six Sigma is highly valued. Strong attention to detail, analytical thinking, and effective communication skills help professionals work collaboratively and document findings precisely. These abilities ensure compliance, data integrity, and the reliability of computerized systems critical to safety and quality.
What is the work of computer system validation?
What degree is best for cis jobs?
What is the salary of SoC validation engineer?

Full-time
Re-posted 2 days ago
Tata Consultancy Services rating
6.5
Based on 21 frontline employees who took The Breakroom Quiz
159th of 210 rated it services
Job description
Tata Consultancy Services is a prominent technology company, and they are seeking a Computer System Validation Lead. The role involves leading end-to-end Computer System Validation activities, ensuring compliance with regulations and quality procedures in regulated environments.
Responsibilities:
• Lead and execute end-to-end CSV activities across the validation lifecycle, ensuring compliance with applicable regulations and internal quality procedures.
• Perform system impact and risk assessments; define validation strategy, scope, and approach (risk-based).
• Author/review validation documentation (VP/VMP, URS, FS/DS, RA, RTM, protocols, reports) and ensure traceability from requirements to testing.
• Develop and execute IQ/OQ/PQ (or equivalent) test scripts; collect and review objective evidence; manage deviations and re-testing.
• Support system release and go-live readiness; ensure security, access control, audit trails, and electronic records/signature controls meet Part 11/Annex 11 expectations.
• Coordinate with IT, Quality, vendors, and business SMEs; review supplier documentation and leverage vendor testing where appropriate.
• Support change control activities (impact assessment, regression testing recommendations, validation closure) and periodic review/maintenance activities.
• Prepare for and support internal/external audits and inspections; respond to auditor queries and contribute to CAPA actions.
• Mentor junior CSV team members; contribute to process improvements, templates, and best practices.
Qualifications:
Required:
• 8–10 years of experience in Computer System Validation (CSV) in regulated (GxP) environments (Pharma / Biotech / MedTech).
• Hands-on experience with validation deliverables: VMP/VP, URS/FS/DS, risk assessments, RTM, IQ/OQ/PQ protocols and reports.
• Strong knowledge of 21 CFR Part 11 and EU Annex 11; ALCOA+ data integrity principles.
• Experience validating SDLC/CSV across system types (e.g., LIMS, MES, QMS, ERP, DMS, Lab instruments, cloud/SaaS applications).
• Familiarity with GAMP 5 and risk-based validation approach.
• Ability to review vendor documentation, perform supplier assessments, and leverage vendor testing.
• Working knowledge of change control, deviation management, CAPA, and periodic review.
• Good documentation practices; strong stakeholder management and communication skills.
Company:
Tata Consultancy Services is a business solutions company that specializes on information technology services and consulting. It is a sub-organization of Tata Group. Founded in 1968, the company is headquartered in Mumbai, IND, with a team of 10001+ employees. The company is currently Late Stage.
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About Tata Consultancy Services
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Tata Consultancy Services is an IT services, consulting and business solutions organization that delivers real results to global business, ensuring a level of certainty no other firm can match. TCS offers a consulting-led, integrated portfolio of IT, BPO, infrastructure, engineering, and assurance services. This is delivered through its unique Global Network Delivery Model™, recognized as the benchmark of excellence in software development. TCS delivers a level of certainty that no other firm can match--to our clients and to our employees. Come join us and experience certainty in your career. TCS a global Consulting and IT Services firm that is ranked in the top quartile by industry analysts. Our 2021 fiscal revenues topped $25 B and our market capitalization is over $170+B, yet we have a deep and large history of philanthropy and corporate social responsibility. Now approaching 600K of the best IT professionals and consultants, we are a trusted advisor, guiding our clients' enterprises through growth and transformation journeys - helping them to become agile, intelligent, automated and on the cloud. We are devoted to DEI and are recognized as a top employer and place to work.