Validation Lead - MES Serialization

About the role As a Validation Lead u2013 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 roleu2019s business requirements, this is a hybrid position requiring 3u20134 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 youu2019re 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. u00b7 _Salary and Other Compensation:_ u00b7 The annual salary for this position is between [$71,100/- to $112,500/-] depending on experience and other qualifications of the successful candidate. u00b7 This position is also eligible for Cognizantu2019s discretionary annual incentive program, based on performance and subject to the terms of Cognizantu2019s applicable plans. u00b7 _Benefits:_ u00b7 Cognizant offers the following benefits for this position, subject to applicable eligibility requirements: u00b7 Medical/Dental/Vision/Life Insurance u00b7 Paid holidays plus Paid Time Off u00b7 401(k) plan and contributions u00b7 Long-term/Short-term Disability u00b7 Paid Parental Leave Employee Stock Purchase PlanCognizant 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.

Created: 2025-11-15