Cognizant · 1 day ago
Validation Lead - MES Serialization
Boston, MA
Full-time
Hybrid
Mid, Senior Level
$71K/yr - $112K/yrCognizant is a leading company in the Life Sciences domain, and they are seeking a Validation Lead – MES Serialization to lead the testing and validation strategy for Document Management Systems. This role involves overseeing interoperability validation, managing Computer System Validation activities, and collaborating with cross-functional teams to ensure compliance with global regulatory standards.
ConsultingIndustrial AutomationInformation TechnologySoftwareSoftware Engineering
No H1B
Responsibilities
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
Qualification
Required
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
Cognizant will only consider applicants for this position who are legally authorized to work in the United States without company sponsorship
Preferred
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
Benefits
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
Company
Cognizant
Cognizant is a professional services company that helps clients alter their business, operating, and technology models for the digital era.
Founded in 1994
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$0.24MKey Investors
Summit Financial Wealth Advisors
2025-03-08Post Ipo Equity
2016-11-18Post Ipo Equity· $0.24M
1998-06-19IPO
Leadership Team
Ravi Kumar S
Chief Executive Officer
Anil Cheriyan
CTO / EVP Strategy & Technology
Recent News
2026-01-08
2026-01-06
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