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
コグニザントのコミュニティ：
私たちは、互いを尊重し支え合う優秀な人材の集まりです。社員一人ひとりが成長し、力を発揮できるよう、エネルギッシュで協力的かつインクルーシブな職場環境を大切にしています。
- コグニザントは、世界中に30万人以上のアソシエイトを擁するグローバルコミュニティです。
- 私たちは、より良い方法を夢見るだけでなく、それを実現します。
- 人、クライアント、企業、地域社会、そして環境に対して、常に「正しいこと」を行うことで責任を果たします。
- あなたにとって最適なキャリアパスを築くことができる、革新的な環境を提供します。
私たちについて：
コグニザント（NASDAQ: CTSH）は、AI builderおよびテクノロジーサービスプロバイダとして、AI投資を企業価値へとつなげるフルスタックのAIソリューションを提供しています。業界、業務プロセス、エンジニアリングに関する深い専門性を強みに、各企業固有のコンテキストをテクノロジーシステムに組み込み、人の力を最大限に引き出すとともに、具体的な成果の創出と、急速に変化する世界におけるグローバル企業の競争力維持を支援します。詳しくは、当社ウェブサイト www.cognizant.com をご覧ください。
コグニザントは機会均等を重視する雇用主です。応募者および候補者は、人種、肌の色、性別、宗教、信条、性的指向、性自認、国籍、障がい、遺伝情報、妊娠、退役軍人の地位、または連邦、州、地方の法律で保護されているその他の特性に基づいて差別されることはありません。
免責事項：
応募者は、対面またはビデオ会議による面接への参加を求められる場合があります。また、各面接の際に、現住所または政府発行の身分証明書の提示が必要となる場合があります。