Lead Lab IT Engineer
Cognizant is a world leader in delivering digital transformation solutions to Life Sciences. Our specialist engineering teams have the aptitude to deliver and support Pharma 4.0 architectures and solutions covering all IT, OT and IoT applications, infrastructures and services.
We are your single end-to-end partner for consultancy, design implementation, optimization and support for all applications in the Pharmaceutical and Biotechnology Manufacturing stack.
Serve as Project Team Lead for a team of IT Lab System Administrators/Engineers for lab workstations and their associated software.
This team's role encompasses comprehensive system lifecycle management from procurement installation and qualification of both GxP lab workstations along with their associated software and supporting infrastructure.
Responsibilities:
* Act as IT Project Lead for QC Lab Support and develop effective working relationships with internal and external stakeholders to ensure customer satisfaction with overall Lab Tech IT project delivery at senior management levels.
* Manage a team of Lab IT Engineers providing technical leadership and mentoring.
* Drive schedule management stakeholder management and coordinate with various project teams and stakeholders.
* Effectively prioritize project team workload and manage capacity to ensure successful delivery of IT related activities to procure setup install relocate and qualify lab systems.
* Manage communication with project stakeholders and be accountable for risk issue and escalation management.
* Guide team for gathering requirements developing design and architecture for new lab workstations and associated software.
* Work with team to assess software deployment options and system integrations to determine the best solutions.
* Coordinate with QC Lab SupportCSV team and vendors for software IOQs.
* Ensure GxP workstations are configured with secure desktop backups and disaster recovery plans to meet regulatory requirements.
* Ensure compliance with FDAs 21 CFR Part 11 EU Annex 11 USP 1058 ISPE GAMP 5.
* Coordinate with IT Cybersecurity Networking Infrastructure and Field Services Leads for lab workstation setup and qualification activities.
* Investigate incidents perform root cause analysis and resolve Lab workstation IT related issues.
* Manage Change Validation DiscrepancyDeviation and CAPAs related to Lab Tech activities.
Requirements:
* Degree in Information Systems Computer Science Engineering or Life Sciences.
* At least 4-5 years experience working in a pharmaceutical laboratory or manufacturing environment with IT Team Lead experience delivering and supporting laboratory instrument or manufacturing equipment systems and working with Infrastructure and Networking teams for servers local area networks etc.
* Experience working with tools such as Microsoft Deployment Toolkit SCCM Active Directory is highly desirable.
* Experience working with GxP software such as Secure Desktop and Nu Genesis SDMS for qualified workstations is also highly desirable.
* Desktop Engineering and networking certifications are highly desirable.
* Experience working with GxP Regulated systems with a focus on data integrity.
* Knowledge of applicable regulations including FDAs GLP and GMP Part 11 and EU Annex 11 and industry guidelines such as ISPE GAMP5 MHRAs GxP Integrity Guidelines and GDPR.
* Proven track record of successful project delivery to meet project deadlines on time and good organization and planning skills.
* Strong leadership communication and critical thinking skills.
* Ability to work independently with minimal direct supervision.
About Us:
Cognizant is one of the world's leading professional services companies, transforming clients' business operating and technology models for the digital era.