Senior LIMS QA Engineer; GxP​/CSV

About the role

As a Senior LIMS QA Engineer (GxP / CSV), you will make an impact by ensuring high quality, compliant, and audit ready validation of LIMS applications and laboratory systems in a regulated environment. You will be a valued member of the Quality Engineering team and work collaboratively with cross functional partners, including business users, validation teams, QA, and laboratory operations.

• Lead validation and testing activities for LIMS platforms, ensuring alignment with GxP, CSV, and 21 CFR Part 11 requirements.
• Develop and execute end‑to‑end validation deliverables including test strategies, test plans, risk assessments, IQ/OQ/PQ protocols, RTMs, and Validation Summary Reports.
• Oversee, review, and guide the creation of validation test scripts to ensure accuracy, compliance, and audit readiness.
• Validate LIMS integrations, interfaces, workflows, laboratory instruments, reports, and data migration activities.
• Partner closely with stakeholders to ensure successful delivery, proactive risk mitigation, and adherence to SDLC/STLC processes in Agile environments.

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 3 days per week onsite at the office in Malvern, PA. 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.

• 10+ years of experience in software testing, with at least 4–5 years as a LIMS Test Lead in regulated environments.
• Strong hands‑on experience with LIMS platforms such as Lab Ware, Thermo Fisher Sample Manager, STARLIMS, or Empower.
• Proven expertise in GxP regulations (GMP, GLP, GCP), Computer System Validation (CSV), and 21 CFR Part 11.
• Deep understanding of data integrity principles (ALCOA+).
• Extensive experience with validation lifecycle activities including test strategy, planning, estimation, risk assessment, IQ/OQ/PQ testing, RTM creation, and VSR documentation.
• Experience reviewing validation test scripts and ensuring systems are audit‑ready.
• Solid knowledge of SDLC/STLC in regulated Agile environments.
• Experience participating in regulatory audits, inspections, or compliance reviews.
• Strong stakeholder management, documentation, and communication skills.
• Hands‑on experience validating LIMS workflows such as sample lifecycle management, QC testing, batch release, stability studies, and instrument integrations.
• Proficiency with test management and defect tracking tools such as JIRA/Xray.
• Experience authoring and executing Functional, Integration, System, Regression, and UAT test cases.
• Strong defect lifecycle management and root cause analysis capabilities.
• Experience with weekly and monthly status reporting, including KPI and metric tracking.

• Exposure to GenAI platforms or the use of AI‑enabled tools in testing or documentation.
• Experience validating complex interfaces, reporting solutions, and multi‑system data flows across LIMS environments.
• Familiarity with data migration validation and large‑scale laboratory system deployments.
• Experience supporting inspection readiness for clients in highly regulated industries.
• Strong analytical mindset with the ability to independently drive quality improvements.

Cognizant will only consider applicants for this position who are legally authorized to work in the United States without company sponsorship. Please note, this role is not able to offer visa transfer or sponsorship now or in the future.

We're excited to meet people who share our mission and can make an impact in a variety of ways. Don't hesitate to apply, even if you only meet the minimum requirements listed. Think about your transferable experiences and unique skills that make you stand out as someone who can bring new and exciting things to this role.

Applications will be accepted until March 15th, 2026.

The annual salary for this position is between $71,100 to 112,500 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.

• 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.