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Director Computer System Validation Csv Jobs in Washington

CSV Lead

Rockville, MD · On-site

$104K - $137K/yr

CSV Lead -- East Coast (Greenfield Pharma/Biotech Program) About the Role We're seeking a CSV (Computer System Validation) Lead to support automation and digital systems validation on a major ...

... computer validation documentation (e.g., URS, FRS, RTM, summary reports) Generate and execute test ... System & Industry Expertise Support CSV activities across various platforms including MES, DCS ...

... computer validation documentation (e.g., URS, FRS, RTM, summary reports) Generate and execute test ... System & Industry Expertise Support CSV activities across various platforms including MES, DCS ...

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

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Veeva Vault RIM Test & Validation Lead (CSV / QEA)

Annapolis, MD • On-site

$71K - $112K/yr

Other

Medical, Dental, Vision, Life, Retirement, PTO

This job post has expired today. Applications are no longer accepted.


Cognizant rating

7.0

Company rating: 7.0 out of 10

Based on 87 frontline employees who took The Breakroom Quiz


Job description

About the role

As a Veeva Vault RIM Test & Validation Lead (CSV / QEA) , you will make an impact by driving validation strategy and ensuring compliance of regulatory systems supporting global submissions. You will be a valued member of the regulatory technology team and work collaboratively with regulatory affairs, quality, and IT stakeholders.

In this role, you will:

Lead validation activities for Veeva Vault RIM, ensuring compliance with GxP and regulatory standards

Develop and execute validation strategies, including risk assessments, test planning, and protocol development

Author and review validation documentation such as validation plans, test scripts, traceability matrices, and reports

Oversee test execution, defect management, and resolution in collaboration with cross-functional teams

Manage change control, demand prioritization, and end-to-end validation lifecycle for regulatory systems

Work model

We believe hybrid work is the way forward as we strive to provide flexibility wherever possible. Based on this role’s business requirements, this is a hybrid position requiring 2-3 days a week in a client or Cognizant office in Boston, MA.

The working arrangements for this role are accurate as of the date of posting. This may change based on the project you’re engaged in, as well as business and client requirements. Rest assured; we will always be clear about role expectations.

What you need to have to be considered

3-5 years of hands-on experience with Veeva Vault RIM (configuration and support)

8+ years of strong experience in Computer System Validation (CSV), including protocol development and compliance

Proven experience in the Life Sciences industry with knowledge of GxP requirements

Understanding of Regulatory Affairs and global submission standards (e.g., eCTD)

Experience with regulatory submission processes and health authority interactions

These will help you stand out

Exposure to AI assurance or validation of AI-enabled systems

Experience estimating testing efforts and planning validation activities across projects

Strong understanding of risk-based validation strategies

Ability to prioritize work based on regulatory impact and business criticality

Experience working in cross-functional or global delivery environments

Salary and Other Compensation

The annual salary for this position is between $71,100 to $112,500, depending on experience and other qualifications of the successful candidate.

This position is also eligible for Cognizant's discretionary annual incentive program, based on performance and subject to the terms of Cognizant's applicable plans.

Benefits:

Cognizant offers the following benefits for this position, subject to applicable eligibility requirements:

Medical/Dental/Vision/Life Insurance

Paid holidays plus Paid Time Off

401(k) plan and contributions

Long-term/Short-term Disability

Paid Parental Leave

Employee Stock Purchase Plan

Cognizant will only consider applicants for this position who are legally authorized to work in the United States without company sponsorship.

Please note, this role is not able to offer visa transfer or sponsorship now or in the future.

Cognizant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

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