Cognizant

Lab Systems Validation Consultant

Cognizant$110K — $130K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • 5-7 years of experience with CSV, FDA regulations, and GAMP 5
  • Direct experience with validation in laboratory systems
  • Domain knowledge in pharmaceuticals is essential
  • Strong communication and technical writing abilities
  • Proficient in developing validation documentation for GLP/GMP/GCP environments
  • Experience in Agile Development preferred
  • Familiarity with Jira or Service Now required

Responsibilities

  • Ensure compliance with CSV, regulatory requirements, and quality management
  • Develop validation plans, specifications, and test protocols for various systems
  • Prepare and execute key validation documents such as URS, IQ, OQ, and PQ
  • Lead the implementation and migration strategies for CSV deliverables
  • Engage in regulatory audits and remediation processes
  • Advise on best practices for CSV and associated documentation
  • Collate and maintain validation artifacts to meet regulatory standards

Benefits

  • Medical, Dental, and Vision Insurance
  • Paid Holidays and Time Off
  • 401(k) plan with contributions
  • Long-term and Short-term Disability Insurance
  • Paid Parental Leave
  • Employee Stock Purchase Plan
Full Job Description
"Please note, this role is not able to offer visa transfer or sponsorship now or in the future." About the role As a Computer System Validation (CSV) Consultant, you will make an impact by ensuring regulated computerized systems, laboratory applications, and digital platforms meet compliance, quality, and validation requirements within the pharmaceutical and life sciences industry. You will be a valued member of the Life Sciences team and work collaboratively with quality, validation, testing, regulatory, business, and technology stakeholders to support compliant system implementations and enhancements. In this role, you will: • Lead Computer System Validation (CSV) activities for laboratory, enterprise, and regulated business systems in GxP environments. • Develop and execute validation deliverables including validation plans, requirements documentation, traceability matrices, test protocols, and validation summary reports. • Partner with business, quality, and technical teams to ensure systems comply with FDA, GAMP, and global regulatory requirements. • Support system implementations, upgrades, migrations, and remediation initiatives through the full system development lifecycle. • Provide guidance on validation best practices, regulatory compliance, risk-based validation approaches, and quality management requirements. 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 attendance at a client or Cognizant office in Boston, MA or San Francisco, CA. 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 • Experience with Computer System Validation (CSV) in regulated pharmaceutical, biotechnology, or life sciences environments. • Strong knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and GxP compliance requirements. • Hands-on experience validating at least one QC, R&D, or laboratory system. • Experience creating and executing validation documentation including URS, Validation Plans, IQ, OQ, PQ, Traceability Matrix, Test Protocols, and Validation Summary Reports. • Experience working within SDLC and V-Model validation frameworks. • Strong technical writing, documentation, and communication skills. • Experience supporting regulatory audits, inspections, remediation activities, and compliance initiatives. • Knowledge of testing methodologies and validation execution for regulated systems. • Ability to collaborate effectively with cross-functional stakeholders. These will help you stand out • Experience with Computer Software Assurance (CSA) methodologies and risk-based validation approaches. • Experience with laboratory automation, process automation, enterprise applications, or network infrastructure validation. • Experience working in Agile delivery environments. • Hands-on experience with Jira, ServiceNow, HP ALM, or similar testing and work management tools. • Experience with test automation frameworks or validation automation tools. • Interest in or exposure to AI-enabled solutions within regulated environments. We're excited to meet people who share our mission and who can make an impact in a variety of ways. Don't hesitate to apply-even if you only meet the minimum requirements. Think about your transferable experiences and unique skills that make you stand out. Salary and Other Compensation: Applications will be accepted until Aug 30, 2026, The annual salary for this position is between $110,000 - $130,000 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 Disclaimer: The salary, other compensation, and benefits 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.

About Cognizant

TriZetto is Powering Integrated Healthcare Management. With technology solutions touching more than half the U.S. population today, TriZetto is uniquely positioned to drive the convergence of core benefit administration, care management and constituent engagement. TriZetto provides premier information technology solutions that enable payers and other constituents in the healthcare supply chain to improve the coordination of benefits and care for healthcare consumers.

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Learn more about Cognizant
Size
340,400 employees
Market Cap
$28.7 billion
Industry
Net Income
$1.3 billion
Founded
1994
5 Year Trend
+6.5%
Revenue
$16.6 billion
NASDAQ

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