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Computer System Validation Director Jobs in Delaware

Prophecy Technologies

R&D CSV Engineer

Wilmington, DE · On-site

This role is for a Computer System Validation (CSV) Engineer with strong R&D domain knowledge, focusing on ensuring GxP compliance for various systems. The engineer will be responsible for applying ...

MSD

Associate Director, Engineering

Wilmington, DE · On-site

In this position the Technical Operations Associate Director will play a pivotal role in ensuring ... Computer System Validation / CSA strategy (if applicable) * Lifecycle management of validated ...

Merck & Co.

In this position the Technical Operations Associate Director will play a pivotal role in ensuring ... Computer System Validation (CSV), Cross-Cultural Awareness, Cross-Functional Teamwork, Equipment ...

Deegit Inc

CSV Lead

Wilmington, DE · On-site

... in Computer Science, Information Technology, or related discipline • Minimum 10+ years of experience in the Information Technology field • 5+ years of pharmaceutical GxP system validation ...

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Computer System Validation Director information

What is a computer system validation director?

Computer System Validation Directors oversee and manage the validation of computer systems within regulated industries, such as pharmaceuticals, biotechnology, or medical devices. Their primary responsibility is to ensure that all computer systems used for business and regulatory purposes comply with industry standards and regulatory requirements, such as FDA or EMA guidelines. They often lead validation teams, develop validation strategies and protocols, and work closely with IT, quality assurance, and compliance departments. This role is crucial to ensure data integrity, patient safety, and regulatory compliance throughout the system lifecycle.

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

To thrive as a Computer System Validation Director, you need expertise in computer system validation (CSV), regulatory compliance (such as FDA 21 CFR Part 11), and a relevant degree in life sciences, engineering, or IT. Familiarity with validation lifecycle management tools, quality management systems (QMS), and knowledge of industry standards like GAMP 5 are typically required. Strong leadership, project management, and communication skills are essential for leading cross-functional teams and ensuring clarity in compliance objectives. These skills are crucial to ensure validated systems meet regulatory requirements, minimize risk, and support organizational quality goals.

What are the main challenges a computer system validation director might face when leading validation projects across multiple global sites?

A Computer System Validation Director often encounters challenges such as navigating differing regulatory requirements across countries, coordinating cross-functional teams in various time zones, and ensuring consistent validation standards are maintained globally. Balancing project timelines with compliance demands can be difficult, especially when local teams have varying levels of validation experience. Strong communication, project management skills, and a deep understanding of international regulations are essential for overcoming these obstacles and ensuring successful, compliant system implementations.

What is the difference between Computer System Validation Director vs Validation Manager?

AspectComputer System Validation DirectorValidation Manager
CredentialsTypically requires a Bachelor's or Master’s in Life Sciences, Engineering, or related fields; certifications like GxP, CSV certificationsSimilar credentials, often with additional certifications in validation or quality assurance
Work EnvironmentLeads validation teams in pharmaceutical, biotech, or medical device companies; strategic roleManages validation activities, oversees teams, and ensures compliance at operational levels
Industry UsageUsed across regulated industries for high-level validation oversightCommonly used in the same industries for day-to-day validation management

The main difference is that the Computer System Validation Director holds a strategic, leadership role overseeing validation programs, while the Validation Manager handles daily validation activities and team management. Both roles require similar credentials and are vital in regulated industries like pharma and biotech.

What are the most commonly searched types of Computer System Validation jobs in Delaware?

The most popular types of Computer System Validation jobs in Delaware are:

What cities in Delaware are hiring for Computer System Validation Director jobs?

Cities in Delaware with the most Computer System Validation Director job openings:

Infographic showing various Computer System Validation Director job openings in Delaware as of August 2026, with employment types broken down into 67% Full Time, and 33% Contract. Highlights an 100% In-person job distribution.

Computer System Validation

Wilmington, DE • On-site

Tata Consultancy Service Limited
IT Services • 10K+ employees
Learn more about Tata Consultancy Service Limitedexternal

$125K - $150K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Re-posted 6 days ago

Tata Consultancy Services rating

6.5

Company rating: 6.5 out of 10

Based on 21 frontline employees who took The Breakroom Quiz

Job description

Must Have Technical/Functional Skills
• 810 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.
Roles & 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.
Salary Range: $125,000 -$150,000 year
TCS Employee Benefits Summary:
Discretionary Annual Incentive.
Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans.
Family Support: Maternal & Parental Leaves.
Insurance Options: Auto & Home Insurance, Identity Theft Protection.
Convenience & Professional Growth: Commuter Benefits & Certification & amp; Training Reimbursement.
Time Off: Vacation, Time Off, Sick Leave & Holidays.
Legal & Financial Assistance: Legal Assistance, 401K Plan, Pe rformance Bonus, College Fund, Student Loan Refinancing.
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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.

Industry

It services

Company size

10,000+ Employees

Headquarters location

Edison, NJ, US

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