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About the role

As a **Validation Lead – MES Serialization** , you will make an impact by leading the testing and validation strategy for enterprise-level Document Management Systems (DMS) within the Life Sciences domain. You will be a valued member of the Quality Engineering & Assurance team and work collaboratively with cross-functional stakeholders including QA, IT, and business teams across global locations.

In this role, you will:

+ Lead the testing strategy for Document Management Systems, ensuring robust, compliant, and efficient processes.

+ Oversee interoperability validation to guarantee seamless integration across platforms and systems.

+ Manage Computer System Validation (CSV) activities in alignment with global regulatory standards (FDA, EMA, MHRA).

+ Utilize ALM tools to streamline testing workflows and ensure traceability across the validation lifecycle.

+ Collaborate with R&D and business teams to align testing efforts with project goals and timelines.

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 3–4 days a week** in a client or Cognizant office in **Boston, MA** . Regardless of your working arrangement, we are here to support a healthy work-life balance through our various wellbeing programs.

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

+ Deep knowledge of GxP regulations and global compliance standards (e.g., 21 CFR Part 11, Annex 11, GAMP 5).

+ Proven expertise in the full validation lifecycle: URS, Risk Assessment, IQ/OQ/PQ, Traceability Matrix, and Validation Summary Reports.

+ Strong documentation and audit readiness skills, including authoring SOPs and validation deliverables.

+ Hands-on experience with MES, Serialization, or OTM/GTM/OPM systems in the pharmaceutical manufacturing domain.

+ Proficiency in tools such as HP ALM, JIRA, ServiceNow, and SharePoint.

These will help you stand out

+ Familiarity with systems like OPM, Informatica, Veeva QMS & DMS, ARVETO 3PL, Oracle Transportation, Global Trade Management, and Oracle EBS.

+ Experience in risk-based validation, deviation handling, CAPA management, and process harmonization.

+ Strong leadership and stakeholder management skills across geographies and time zones.

+ Exposure to Agile, Waterfall, and V-Model SDLC methodologies.

+ A proactive mindset with a commitment to continuous learning and professional development.

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

We're excited to meet people who share our mission and can make an impact in a variety of ways. Don't hesitate to apply, even if you only meet the minimum requirements listed. Think about your transferable experiences and unique skills that make you stand out as someone who can bring new and exciting things to this role.

•** **_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 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.