The role involves leading end-to-end Computer System Validation activities, ensuring compliance ... evidence; manage deviations and re-testing. • Support system release and go-live readiness ...
The role involves leading end-to-end Computer System Validation activities, ensuring compliance ... evidence; manage deviations and re-testing. • Support system release and go-live readiness ...
COMPUTER SYSTEM VALIDATION LEAD Wilmington, DE Fulltime 10+ years of experience Must Have ... management, CAPA, and periodic review. • Good documentation practices; strong stakeholder ...
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COMPUTER SYSTEM VALIDATION LEAD Wilmington, DE Fulltime 10+ years of experience Must Have ... management, CAPA, and periodic review. • Good documentation practices; strong stakeholder ...
Computer validation Engineer
$107K - $127K/yr
Candidate will take direction from Lead Automation Engineer/Project Manager. Execute Computer System validation (CSV) protocols. Write and resolve protocol deviations. Write test summary reports.
Computer validation Engineer
$107K - $127K/yr
Candidate will take direction from Lead Automation Engineer/Project Manager. Execute Computer System validation (CSV) protocols. Write and resolve protocol deviations. Write test summary reports.
Associate Director, QA Computer System Validation
Radnor, PA · On-site
$184K - $215K/yr
Manage risk assessments with functional teams to assess system risks and develop mitigations ... computer system validation/qualification, or related areas * Experience with systems such as Veeva ...
Associate Director, QA Computer System Validation
Radnor, PA · On-site
$184K - $215K/yr
Manage risk assessments with functional teams to assess system risks and develop mitigations ... computer system validation/qualification, or related areas * Experience with systems such as Veeva ...
Associate Director, QA Computer System Validation
Radnor, PA · Hybrid
$184K - $215K/yr
Manage risk assessments with functional teams to assess system risks and develop mitigations ... computer system validation/qualification, or related areas * Experience with systems such as Veeva ...
Associate Director, QA Computer System Validation
Radnor, PA · Hybrid
$184K - $215K/yr
Manage risk assessments with functional teams to assess system risks and develop mitigations ... computer system validation/qualification, or related areas * Experience with systems such as Veeva ...
CSV Lead/ Computer System Validation Lead
$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
$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.
Validation Manager
$90K - $155K/yr
Validation Manager The Validation Manager leads the end-to-end planning, coordination, and ... Maintain a high standard of inspection readiness by ensuring documentation, processes, and systems ...
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Validation Manager
$90K - $155K/yr
Validation Manager The Validation Manager leads the end-to-end planning, coordination, and ... Maintain a high standard of inspection readiness by ensuring documentation, processes, and systems ...
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
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 ...
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 ... Leadership experience managing and developing validation teams, governance frameworks, and scalable ...
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 ... Leadership experience managing and developing validation teams, governance frameworks, and scalable ...
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 ... Leadership experience managing and developing validation teams, governance frameworks, and scalable ...
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 ... Leadership experience managing and developing validation teams, governance frameworks, and scalable ...
Digital Systems Validation Lead
Wayne, PA · Hybrid
$116K - $130K/yr
Master's degree preferred * 8+ years of experience in computer system validation within regulated ... Leadership experience managing and developing validation teams, governance frameworks, and scalable ...
Digital Systems Validation Lead
Wayne, PA · Hybrid
$116K - $130K/yr
Master's degree preferred * 8+ years of experience in computer system validation within regulated ... Leadership experience managing and developing validation teams, governance frameworks, and scalable ...
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
Guide testing readiness activities, CMDB governance, and validation tool utilization while ensuring ... Computer System Validation (CSV) / Computer System Assurance within regulated life sciences
6420 - Senior CSV Engineer / Senior Validation Engineer
King Of Prussia, PA · Remote
$104K - $142K/yr
Guide testing readiness activities, CMDB governance, and validation tool utilization while ensuring ... Computer System Validation (CSV) / Computer System Assurance within regulated life sciences
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 ...
MES system implementation * Recipe management * User requirement specification development ... We require a minimum BS Degree in Engineering (Computer Science, Electronics, Electrical, Chemical ...
MES system implementation * Recipe management * User requirement specification development ... We require a minimum BS Degree in Engineering (Computer Science, Electronics, Electrical, Chemical ...
Compliance & Risk Management * Ensure alignment with: * GAMP 5 Second Edition * Computer Software ... Pharmaceutical Manufacturing, Quality, or R&D systems
Compliance & Risk Management * Ensure alignment with: * GAMP 5 Second Edition * Computer Software ... Pharmaceutical Manufacturing, Quality, or R&D systems
Senior Lab Systems Support Engineer (Pharma)
West Point, PA · On-site
$101K - $138K/yr
Support Computer System Validation activities, including qualification documentation, testing, and change implementation. * Participate in Change Control, Deviation, CAPA, and Problem Management ...
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Senior Lab Systems Support Engineer (Pharma)
West Point, PA · On-site
$101K - $138K/yr
Support Computer System Validation activities, including qualification documentation, testing, and change implementation. * Participate in Change Control, Deviation, CAPA, and Problem Management ...
New
Senior Automation Validation Engineer
Blue Bell, PA · On-site
$99K - $130K/yr
Experience with SCADA, MES, and database systems, or computer system validation are considered a plus. * Project Management experience and Process Knowledge isa plus Job Type: Full-time
Senior Automation Validation Engineer
Blue Bell, PA · On-site
$99K - $130K/yr
Experience with SCADA, MES, and database systems, or computer system validation are considered a plus. * Project Management experience and Process Knowledge isa plus Job Type: Full-time
Hands-on experience with Windows patching, antivirus deployment, asset inventory management, network security, and access management. * Experience with Change Control, GxP, Computer System Validation ...
New
Hands-on experience with Windows patching, antivirus deployment, asset inventory management, network security, and access management. * Experience with Change Control, GxP, Computer System Validation ...
New
Computer System Validation Manager information
See Lansdowne, PA salary details
$44.8K - $54.4K
1% of jobs
$54.4K - $64.1K
4% of jobs
$72.2K is the 25th percentile. Wages below this are outliers.
$64.1K - $73.8K
24% of jobs
$73.8K - $83.5K
9% of jobs
The median wage is $90.5K / yr.
$83.5K - $93.2K
17% of jobs
$93.2K - $102.9K
8% of jobs
$102.9K - $112.5K
5% of jobs
$119.1K is the 75th percentile. Wages above this are outliers.
$112.5K - $122.2K
11% of jobs
$122.2K - $131.9K
8% of jobs
$131.9K - $141.6K
6% of jobs
$141.6K - $151.3K
8% of jobs
$44.8K
$99.4K
$151.3K
How much do computer system validation manager jobs pay per year?
What are the key skills and qualifications needed to thrive as a Computer System Validation Manager, and why are they important?
What are some common challenges a Computer System Validation Manager faces during system implementation projects?
What does a Computer System Validation Manager do?
What is the difference between Computer System Validation Manager vs Computer System Validation Specialist?
| Aspect | Computer System Validation Manager | Computer System Validation Specialist |
|---|---|---|
| Certifications | GAMP, CQE, CSQE | GAMP, CQE, CSQE |
| Work Environment | Management, oversight, strategic planning | Execution, testing, documentation |
| Industry Usage | Pharmaceutical, biotech, regulated industries | Pharmaceutical, biotech, regulated industries |
| Primary Focus | Leading validation projects, team coordination | Performing validation activities, testing |
The main difference between a Computer System Validation Manager and a Computer System Validation Specialist lies in their roles. The manager oversees validation projects, manages teams, and ensures compliance, while the specialist executes validation tasks and documents testing procedures. Both roles require similar certifications and are vital in regulated industries like pharmaceuticals and biotech.
Full-time
Re-posted 3 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.