Senior Laboratory Systems Support EngineerJob SummaryCognizant 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 ResponsibilitiesLaboratory 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.
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.
