The Role
Cognizant is seeking a Senior Business Analyst – Laboratory Systems to lead business analysis activities supporting the design, implementation, and validation of modern laboratory environments. In this role, you will partner closely with business stakeholders, IT, Quality, and vendors to ensure laboratory systems and processes meet business needs while complying with regulatory, data integrity, and Computer System Validation (CSV) requirements.
You will play a critical role in aligning business requirements, regulatory expectations, and technical solutions across GxP‑regulated laboratory operations.
Key Responsibilities
Business & Regulatory Requirements
- Elicit, analyze, and document business and functional requirements through stakeholder interviews and facilitated workshops
- Author and maintain key deliverables, including BRD, URS, FRS, and RTM
- Ensure adherence to ALCOA+ data integrity principles and applicable regulatory requirements
Process Analysis & Improvement
- Assess current laboratory operations and workflows
- Develop As‑Is and To‑Be process maps
- Identify opportunities for process optimization, standardization, and risk reduction
Solution & Impact Assessment
- Support feasibility and impact analysis for proposed IT and laboratory solutions
- Evaluate implications of system, process, or configuration changes
- Ensure alignment between business needs, compliance expectations, and technical design
Laboratory Systems Implementation Support
- Support implementations and enhancements of laboratory systems such as LIMS, CDS, ELN, Empower, and laboratory instrumentation
- Assist with system configuration, integrations, and interface requirements
Stakeholder Communication & Collaboration
- Act as a liaison between business users, IT teams, Quality, and external vendors
- Drive alignment on objectives, scope, and issue resolution across project teams
Project & Validation Support
- Contribute to project planning, tracking, and status reporting
- Support validation strategy development, planning, and execution activities
GxP Compliance & CSV
- Author and review validation documentation in alignment with CSV lifecycle expectations
- Maintain requirement traceability throughout the project lifecycle
- Support audit readiness, inspections, and change control activities
Vendor & Cross‑Functional Coordination
- Collaborate with lab engineers, QA, system integrators, and vendors
- Review vendor documentation to ensure suitability for GxP‑regulated environments
Risk & Data Integrity Management
- Participate in risk assessments to identify compliance and data integrity risks
- Identify, assess, and help mitigate data integrity vulnerabilities
Data Migration & Infrastructure Support
- Define data migration and data retention requirements
- Support strategies for backups, archival, audit trails, and data availability
Required Qualifications
- Bachelor’s degree or equivalent practical experience
- Extensive experience supporting GxP‑regulated laboratory environments as a Business Analyst
- Strong knowledge of CSV, data integrity, and regulatory compliance
- Experience with laboratory systems such as LIMS, CDS, ELN, Empower, or similar platforms
- Proven ability to lead stakeholders and translate business needs into clear, compliant documentation
Preferred Qualifications
- Experience supporting laboratory modernization or new lab build initiatives
- Familiarity with FDA, EMA, and global regulatory expectations
- Consulting or multi‑client delivery experience
Work Model
Hybrid role based in Foster City, CA, with on‑site presence required per project and client needs.
Equal Opportunity Statement
Cognizant is an equal opportunity employer and committed to creating a diverse and inclusive workforce.
Salary & Compensation (U.S.)
The annual base salary for this role, if hired in the United States, is $95,000 – $120,000 USD, depending on experience, skills, geographic location, and other business considerations.
This position is also eligible for Cognizant’s discretionary annual incentive program, subject to company and individual performance.
Benefits (U.S.)
Cognizant offers a comprehensive benefits package to support our associates’ health, wellbeing, and professional growth, including:
- Medical, Dental, and Vision Insurance (multiple plan options)
- Paid Time Off (PTO) and Paid Holidays
- 401(k) Retirement Savings Plan with company match
- Life Insurance and Accidental Death & Dismemberment (AD&D) coverage
- Short‑Term and Long‑Term Disability Insurance
- Flexible Spending Accounts (FSA) and Health Savings Accounts (HSA)
- Employee Assistance Program (EAP)
- Tuition Reimbursement and Learning & Development Programs
- Parental Leave and Family Support Benefits
- Wellbeing and Wellness Programs
The Cognizant community:
We are a high caliber team who appreciate and support one another. Our people uphold an energetic, collaborative and inclusive workplace where everyone can thrive.
- Cognizant is a global community with more than 300,000+ associates around the world.
- We don’t just dream of a better way – we make it happen.
- We take care of our people, clients, company, communities and climate by doing what’s right.
- We foster an innovative environment where you can build the career path that’s right for you.
About us:
Cognizant (Nasdaq: CTSH) is an AI Builder and technology services provider, building the bridge 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, realize tangible returns and keep global enterprises ahead in a fast-changing world. See how at www.cognizant.com or @cognizant.
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.
Disclaimer:
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.