A Validation Specialist tests and documents the validity and accuracy of manufacturing systems and equipment. Tests processes and manages process validations. Provides technical support and implements operating procedures. May create documentation to show that a manufacturing or production process has consistent results and meets quality standards.
"Please note, this role is not able to offer visa transfer or sponsorship now or in the future." Lab Systems Validation Consultant About the role As a Lab Systems Validation Consultant, you will make an impact by ensuring laboratory and computerized systems meet regulatory, quality, and validation requirements within Life Sciences environments. You will be a valued member of the Quality and Validation team and work collaboratively with laboratory operations, quality assurance, IT, validation, and business stakeholders to support compliant system implementations, upgrades, and ongoing validation activities. In this role, you will: Lead Computerized System Validation (CSV) activities for laboratory systems used in regulated pharmaceutical environments. Develop, review, and execute validation deliverables including Validation Plans, URS, MVP, RTM, IQ, OQ, PQ, VSR, test protocols, and standard operating procedures. Partner with cross-functional teams to ensure laboratory systems comply with
FDA 21 CFR
Part 11, EU Annex 11, GAMP 5, GxP, and applicable quality requirements. Support system implementations, upgrades, migrations, and remediation activities while ensuring validation documentation meets regulatory expectations. Provide guidance on validation strategies, testing activities, risk assessments, compliance requirements, and continuous improvement initiatives across laboratory and enterprise systems. 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 time in a client or Cognizant office in Spring House, Pennsylvania . 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 Bachelor's degree in Life Sciences, Engineering, Computer Science, Information Technology, or a related discipline. Hands-on experience with Computerized System Validation (CSV) in pharmaceutical, biotechnology, or other regulated Life Sciences environments. Experience validating at least one laboratory system within QC, R D, or other laboratory environments. Strong knowledge of
FDA 21 CFR
Part 11, EU Annex 11, GAMP 5, SDLC, validation lifecycle methodologies, and GxP requirements. Experience preparing and executing validation documents including IQ, OQ, PQ, RTM, Validation Plans, Validation Summary Reports, and test protocols. Experience supporting GLP, GMP, and GCP computerized systems and validation programs. Strong technical writing, documentation, communication, and stakeholder management skills. Experience with testing activities, defect management, and validation execution using tools such as Jira, ServiceNow, HP ALM, or similar platforms. These will help you stand out Experience with Computer Software Assurance (CSA) methodologies and risk-based validation approaches. Experience supporting regulatory audits, inspection readiness, remediation programs, and compliance initiatives. Knowledge of validation activities across laboratory automation, process automation, enterprise applications, and network infrastructure. Experience working in Agile delivery environments. Familiarity with AI-enabled validation, testing, or quality management solutions. Experience supporting system migrations, validation due diligence, and GxP/non-GxP assessments. 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.
Salary and Other Compensation :
Applications will be accepted until August 18th, 2026. The annual salary for this position is between $90,000 - $109,000 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.
