Senior Laboratory Systems Support Engineer
Job Summary
Cognizant is seeking a Senior Laboratory Systems Support Engineer to support and enhance laboratory systems, analytical instruments, and associated data workflows within a regulated pharmaceutical environment. This role is responsible for the lifecycle management of laboratory computerized systems, ensuring compliance with GxP requirements, data integrity standards, and regulatory expectations.
The ideal candidate combines laboratory systems knowledge, IT support expertise, and a strong understanding of pharmaceutical quality and compliance requirements. This role partners closely with Laboratory Operations, Quality Assurance, IT, and external vendors to ensure reliable, compliant, and efficient laboratory system performance.
Key Responsibilities
Laboratory Systems Lifecycle Management
- Manage the end-to-end lifecycle of laboratory systems, including implementation, validation, maintenance, upgrades, and retirement.
- Support Software Development Lifecycle (SDLC), Computer System Validation (CSV), and GxP compliance activities.
- Coordinate system patching, backup, restoration, archival, and disaster recovery activities.
- Maintain audit readiness through accurate documentation and adherence to validation and compliance requirements.
- Support onboarding and decommissioning of laboratory systems and applications.
Laboratory Systems Support
- Provide Level 1 and Level 2 support for laboratory software applications and instrument integration platforms.
- Troubleshoot software, hardware, and connectivity issues affecting laboratory systems and analytical instruments.
- Coordinate with desktop, network, and infrastructure support teams to resolve hardware and network-related issues.
- Manage user access activities, including account creation, modification, and deactivation in accordance with established procedures.
- Perform routine backup and restoration activities for standalone, benchtop, and enterprise laboratory systems.
- Support software installations, upgrades, and configuration management activities.
Vendor Management and Coordination
- Serve as the primary point of contact for laboratory system vendors and service providers.
- Coordinate vendor-led installations, maintenance activities, repairs, and upgrades.
- Monitor vendor performance against service level agreements (SLAs).
- Manage vendor documentation, deliverables, issue tracking, and escalation management.
- Facilitate vendor engagement during system incidents, hardware failures, and scheduled maintenance activities.
Compliance and Quality Support
- Ensure laboratory systems operate in compliance with GLP, GMP, GxP, data integrity, and regulatory requirements.
- Support Computer System Validation activities, including qualification documentation, testing, and change implementation.
- Participate in Change Control, Deviation, CAPA, and Problem Management processes.
- Maintain system-related procedures, SOPs, work instructions, and technical documentation.
- Support internal, customer, and regulatory audits by providing system documentation, evidence, and responses to audit inquiries.
Cross-Functional Collaboration
- Partner with laboratory personnel, Quality Assurance, Validation, and IT teams to resolve issues and improve system performance.
- Collaborate with stakeholders to optimize laboratory workflows and system utilization.
- Participate in continuous improvement initiatives that enhance operational efficiency, compliance, and data integrity.
- Support laboratory business processes by ensuring systems align with operational and regulatory requirements.
Required Qualifications
- Bachelor's degree in Life Sciences, Computer Science, Information Technology, Engineering, or a related discipline.
- Experience supporting laboratory systems within the pharmaceutical, biotechnology, healthcare, or regulated life sciences industry.
- Good understanding of GxP regulations, including GMP, GLP, and data integrity requirements.
- Knowledge of Computer System Validation (CSV) principles and regulatory compliance expectations.
- Experience supporting laboratory software and instrument integration environments.
- Familiarity with analytical laboratory instruments such as HPLC, GC, spectrophotometers, or similar technologies.
- Experience using IT service management and ticketing platforms such as ServiceNow, Remedy, or equivalent.
- Understanding of Change Management, Deviation Management, CAPA, and Problem Management processes.
- Strong troubleshooting, analytical, and problem-solving skills.
- Excellent verbal and written communication skills.
- Ability to work effectively in a cross-functional and highly regulated environment.
Preferred Qualifications
- Experience supporting laboratory informatics platforms such as CDS, LIMS, ELN, SDMS, or laboratory integration solutions.
- Familiarity with FDA 21 CFR Part 11 and Annex 11 compliance requirements.
- Experience supporting audit readiness and regulatory inspections.
- Knowledge of system backup, restoration, and disaster recovery processes.
- Understanding of pharmaceutical laboratory operations and analytical workflows.
- Exposure to validation documentation, testing protocols, and qualification activities.
Why Cognizant
At Cognizant, we help some of the world's leading life sciences organizations accelerate innovation and improve patient outcomes through technology, data, and digital transformation. You'll work with talented professionals on impactful projects in a collaborative and inclusive environment while continuing to grow your career and technical expertise.
We are committed to fostering a culture that values diversity, inclusion, continuous learning, and professional development.
Equal Opportunity Employer
Cognizant is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace where all employees are respected, valued, and empowered to succeed. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by applicable law.
Location: Rahway, New Jersey, United States (Hybrid)
Work Model: Hybrid. Associates are expected to work onsite and remotely in accordance with business and client requirements.
Salary and Other Compensation:
The annual salary for this position is $90,000 - $120,000, depending on experience, qualifications, skills, and location.
This position is also eligible for Cognizant's discretionary annual incentive program, subject to plan terms and individual performance. Benefits include medical, dental, vision, life insurance, paid holidays, paid time off, 401(k), and other benefits in accordance with applicable plans and programs.
What we offer
- The chance to work with impact. Here, you’re empowered to bring your biggest thinking to help our company and clients improve everyday life.
- Ownership over your career. Stay at the top of your game through our award-winning learning and development ecosystem. And when your ambitions change or we offer new opportunities, we help you pivot by providing reskilling, on-the-job learning and guidance to find new roles that might be a better fit.
- The opportunity to thrive on a high caliber team with heart. We celebrate each other’s experiences and perspectives and promote a sense of belonging through our affinity groups and diversity and inclusion initiatives.
- A comprehensive total rewards package, including a competitive salary and a pension plan with matching contributions.
- Flexible health and financial benefits to support you and your eligible dependents—from day one.
- True work-life balance. Be at your best through paid time off, flexible work arrangements, volunteering opportunities, social events, and so much more.
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.
Other employment-related information
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, provincial or local laws.
If you have a disability that requires reasonable accommodation to search for a job opening or submit an application, please email [email protected] with your request and contact information.
Language requirements vary depending on roles, but we ask that all candidates have basic English proficiency for company-wide communications purposes. For roles based in Quebec, professional English proficiency is required, as you’ll deliver services to and collaborate with stakeholders outside the province who may not speak French.
