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Lead MES Syncade Validation Engineer

00070951121

Job Summary

Lead MES Validation - The Lead MES Syncade Validation Engineer leads the validation strategy and execution for Syncade MES and related systems in a GxP-regulated life science manufacturing environment. The role ensures electronic batch records recipes and integrations are validated per GAMP 5 21 CFR Part 11 and EU Annex 11 while mentoring the validation team and maintaining inspection-ready compliance and data integrity.

Responsibilities

  • Lead the validation strategy planning and execution for Syncade MES projects upgrades and site rollouts using a risk-based GAMP 5 approach
  • Author and review validation deliverables including validation plans URS FS/DS risk assessments IQ/OQ/PQ protocols traceability matrices and summary reports
  • Oversee testing of Syncade EBRs master recipes workflows and integrations with DeltaV ERP (e.g. SAP) LIMS and historians
  • Ensure compliance with 21 CFR Part 11 EU Annex 11 and data integrity (ALCOA+) requirements including audit trails and electronic signatures
  • Manage change controls deviations CAPAs and impact assessments to keep systems in a validated state throughout the lifecycle
  • Provide technical leadership mentoring and work direction to validation engineers testers and contractors
  • Collaborate with QA Manufacturing IT Automation and vendors to align requirements resolve test failures and approve deliverables
  • Define and maintain validation SOPs templates and standards and drive adoption of global validation practices across sites
  • Support periodic reviews internal audits and regulatory inspections as the subject matter expert for Syncade validation
  • Identify opportunities to streamline validation through automation reusable test scripts and computer software assurance (CSA) principles

Additional employment information
Compensation information is accurate as of the date of this posting. Cognizant reserves the right to modify this information at any time, subject to applicable law.

Applicants may be required to attend interviews in person or by video conference. In addition, candidates may be required to present their current state or government issued ID during each interview.

Cognizant is an equal opportunity employer. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws.

Applicants must be currently authorized to work for any employer in the United States. The company is unable to provide employment-based immigration sponsorship for this position.

If you have a disability that requires reasonable accommodation to search for a job opening or submit an application, please email [email protected] with your request and contact information.

About Cognizant: 
Cognizant (Nasdaq: CTSH) is an AI Builder and technology services provider, bridging the gap between AI investment and enterprise value by building full-stack AI solutions for our clients. Our deep industry, process and engineering expertise enables us to build an organization’s unique context into technology systems that amplify human potential, drive tangible outcomes and keep global enterprises ahead in a fast-changing world. See how at cognizant.ai or @cognizant.

 

Benefits that help you thrive and grow

Our benefits program is built with you in mind—so you can enjoy a fulfilling, balanced and healthy life.

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Financial wellbeing

We regularly review market data to ensure compensation reflects the value you bring. Your benefits extend beyond pay and may include retirement plans, financial education, etc.

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Physical and mental health

We empower you to prioritize your wellbeing through paid time off, flexible working where possible, healthcare plans, counselling, our Mental Health Allyship program and more. 

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Your career, your way

With 350,000+ roles at Cognizant, you’ll have opportunities explore new technologies, industries and locations—and build the skills you need to grow your career.

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Real-world impact

Think about the biggest brands you rely on. Chances are, they rely on us to help strengthen their business. Here, you’ll turn bold ideas into solutions that improve lives everywhere.

Your path to Cognizant

Here’s what you can expect from our hiring process. Please keep in mind that it may vary by role and location. Explore our FAQs to learn more.

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Step 1: Apply to the right opportunity

Find an open role that matches your skills and career goals and show us why you’re the person for the job. Don’t see the right opportunity? Consider joining our Talent Community.

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Step 2: Connect with your recruiter

If one of our recruiters sees a fit, they’ll set up a short intro call to learn more about you and how your experiences and skills match the role.

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Step 3: Show off your skills

If you and our team would like to continue the process, you’ll interview with our hiring team. Some roles may also require technical assessments and/or client interviews.

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Step 4: Decision time

Our team will then review each candidates’ potential to succeed in the role. This step may take some time because we want to find the right fit for both you and us—but you can count on us to keep you updated.

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