Lupin is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and commercial divisions. Together these entities make up the generic and branded U.S. business. Lupin has a significant generic pipeline, and a branded focus on women’s health. Our first Research and Development facility in the US is located in Coral Springs, Florida which focuses on generic and branded orally inhaled and nasal drug products. Somerset, New Jersey is home to one of Fifteen commercial manufacturing sites globally and the only commercial manufacturing facility in the United States for Lupin, as well as additional Research and Development teams. Lupin is prided on being people-focused and centered around how impactful we are with our customers. Dollars are not a measure of success but rather the people we help along the way.
Responsibilities
Role Summary
Manage site IT operations in an R&D and GMP facility with multiple internal & external stakeholders & be accountable for Core Infrastructure operations in Coral Springs and Naples. Establish connect & relationships with business & central IT stakeholders
Essential Duties and Responsibilities
IT Infrastructure management:
Accountable for running the site IT operations efficiently. Including Server & Network Monitoring, Link Monitoring and End User Support services.
Budgeting & Tracking
Identify improvement opportunities in Site IT and execute (in sync with global guidelines & governance)
Drive site projects (as part of larger global initiatives or site specific) for example- Infosec projects/ Cloud Migrations/ DC Interventions/Quality monitoring or R&D Applications/Physical security systems
Site contracts & licensing renewals
Ability to collaborate and network across the organization to improve role effectiveness. Provide
Collaborate with vendors/ India teams/ inhouse teams to resolve complex issues and roll out new services.
Conduct DR & restore drills for critical applications
Vendor coordination for plant and R&D systems
Manage & Track IT Inventory (software & hardware)- including Asset Register
Support site Audits & Manage Software License Compliance
Ensure site IT SOPs are updated. Accountable for compliance to those SOPs.
Accountable for resolving server/storage/patching/backup related issues pertaining to site.
Site Quality / CSV support:
Aid Quality Investigations with respect to IT systems.
Oversee CSV activities and manage validation lifecycle.
Create and maintain GMP documentation.
Application support front ending:
Frontend for Application support / application projects.
Liaison with corporate IT support for ticket resolution.
Qualifications
Education and Experience:
Masters/ Bachelors IT or similar desired Certifications.
Overall experience 15-20 yrs (with IT Manager experience 5-10 yrs)
Exposure & Knowledge IT Infra & Networking- Data Center/ Server Admin/ Firewalls/ Switches/ Communication Links/ Active Directory/ Domains/ O365/ Patching/ Backups/ DR Drills and Restore/ Mfg & Lab Systems Management etc.- including installations and vendor coordination.
Software Licensing & Compliance.
Knowledge of SAP/ Trackwise systems desired.
Knowledge & Experience of 21CFR Part11 compliance in IT Operations.
Candidate should have worked in a similar role for a Pharma plant or R&D site.
Knowledge of Quality/ Supply Chain/ Operations/ Sales & Commercial/ LIMS/ EHS/ Electronic Batch Record Systems/ Plant Automation/ Building Automation, etc.
Candidate should have knowledge of GMP processes; Computer system validation (CSV).
Possess ability to manage conflict & ambiguity.
Manage indirect teams
Hands-on knowledge of the following technologies:
Windows OS 7/8/10/11
Server OS 2012/2016/2019/2022
DHCP, DNS, IP Subnetting, Active Directory, Group policies. Azure AD, O365, Teams and Intune.
WSUS, SCCM, third party patching tools.
VMWare, Hyper V, Vmotion, VCenter management console, vSphere Replication
ManageEngine Active Directory Plus, Lansweeper, Solar Winds, IT ticketing tools, ITIL understanding.
Teams Room System
Lupin is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veteran’s status, or any other classification as required by applicable law.
Physical Requirements
The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Generally work is performed in an office environment.
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full-time