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Computer System Validation Manager Jobs in Delaware

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 ...

MSD

Senior Specialist, Quality Assurance

Wilmington, DE

$80K - $110K/yr

Adaptability, Aseptic Operations, Business Continuity, cGMP Compliance, Computer System Validation ... Change Management, Continuous Improvement, Data Integrity, Good Automated Manufacturing Practice ...

Delaware Electric Cooperative

Manager of GIS

Greenwood, DE

$75K - $101K/yr

Knowledge: Must have a working knowledge of computer operating systems and software programs ... Manager of GIS manages Geospatial Technicians and mapping related vendor relationships using an ...

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Computer System Validation Manager information

What are the key skills and qualifications needed to thrive as a Computer System Validation Manager, and why are they important?

To thrive as a Computer System Validation Manager, you need expertise in computer system validation regulations (such as GxP, FDA 21 CFR Part 11), strong project management skills, and a background in life sciences or IT. Familiarity with validation lifecycle documentation tools, quality management systems (QMS), and compliance software is often required, along with relevant certifications like PMP or CSV-related credentials. Exceptional attention to detail, analytical thinking, and effective communication are crucial soft skills for coordinating cross-functional teams and ensuring regulatory compliance. These skills and qualifications are vital to ensure validated systems meet regulatory standards, minimize compliance risks, and support organizational quality objectives.

What are some common challenges a Computer System Validation Manager faces during system implementation projects?

A Computer System Validation Manager often encounters challenges such as aligning validation activities with evolving regulatory requirements, managing tight project timelines, and coordinating between multiple stakeholders like IT, Quality Assurance, and business users. Ensuring thorough documentation and traceability, while adapting to technology updates or scope changes, can also be demanding. Proactive communication and strong project management skills are essential to mitigate risks and ensure successful, compliant system implementations.

What does a Computer System Validation Manager do?

A Computer System Validation Manager is responsible for ensuring that computer systems used in regulated industries, such as pharmaceuticals or biotechnology, meet all required compliance standards. They oversee the planning, execution, and documentation of validation activities to ensure systems are reliable, accurate, and secure. Their duties include managing validation projects, writing protocols, coordinating with IT and quality assurance teams, and ensuring adherence to regulations like FDA 21 CFR Part 11. This role is critical for maintaining product quality and regulatory compliance.

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

AspectComputer System Validation ManagerComputer System Validation Specialist
CertificationsGAMP, CQE, CSQEGAMP, CQE, CSQE
Work EnvironmentManagement, oversight, strategic planningExecution, testing, documentation
Industry UsagePharmaceutical, biotech, regulated industriesPharmaceutical, biotech, regulated industries
Primary FocusLeading validation projects, team coordinationPerforming 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.

What are popular job titles related to Computer System Validation Manager jobs in Delaware? For Computer System Validation Manager jobs in Delaware, the most frequently searched job titles are:
What job categories do people searching Computer System Validation Manager jobs in Delaware look for? The top searched job categories for Computer System Validation Manager jobs in Delaware are:
What cities in Delaware are hiring for Computer System Validation Manager jobs? Cities in Delaware with the most Computer System Validation Manager job openings:
Computer System Validation Manager jobs near you
Infographic showing various Computer System Validation Manager job openings in Delaware as of July 2026, with employment types broken down into 57% Full Time, and 43% Contract. Highlights an 100% In-person job distribution.
Computer System Validation Lead

Computer System Validation Lead

Tata Consultancy Services

Wilmington, DE • On-site

Full-time

Posted 10 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

159th of 210 rated it services

Job description

Job Summary:
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 (TCS) is the technology partner of choice for industry leading organizations worldwide. Founded in 1992, the company is headquartered in Puteaux, FRA, 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.

Industry

It services

Company size

10,000+ Employees

Headquarters location

Edison, NJ, US

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