Celltrion Inc · 18 hours ago
IT Principal Systems Engineer
Branchburg, NJ
Full-time
Hybrid
Senior Level, Lead/Staff
$118K/yr - $158K/yr
5+ years expCelltrion Inc is a company focused on innovative solutions in the pharmaceutical industry, and they are seeking an IT Principal Systems Engineer to design, analyze, implement, and troubleshoot information systems. The role involves managing Windows Server environments, ensuring compliance with security standards, and serving as a technical lead on computer system validation projects.
Health CarePharmaceutical
Responsibilities
Design, implement, and maintain Windows Server environments, including physical and virtual server provisioning, monitoring, storage, and capacity planning
Experience in enterprise-level Windows System Administration/Engineering
Ensure server infrastructure meets security standards through patch management, vulnerability remediation, and hardening of Active Directory and OS
Act as a high-level technical resource for complex server outages, performance issues, and root cause analysis
Create documentation for systems, configurations, and procedures, while recommending future infrastructure changes
Author, review, approve and execute computer systems validation deliverables
Perform and/or review periodic reviews of qualified computer systems maintained by the department
Provide computer system validation support for the IT department with a focus on the Quality Assurance requirements
Serve as a technical lead on multiple computer system validation projects, driving the technical implementation and design/configuration of these systems required to achieve group and corporate objectives (also reviewing validation documentation and executing IQ/OQ/PQ protocols as needed)
Serve as a technical lead for the initiation and management of change controls related to computer systems
Ensure that validated computerized systems are maintained in a manner compliant with corporate and regulatory requirements (including 21 CFR Part 11)
Identify compliance issues and process improvements related to the ongoing administration of computerized systems, implementing effective resolutions
Provide input to lead technical projects within the department, as needed
Work independently to draft/review system administration procedures and policies
Serve as a primary interface with system owners, IT, QA, and vendors related to computerized systems
Key contact for stakeholders\customers for IT related changes\incidents
Act as Lead\Subject Matter Expert among peers in the IT area
Qualification
Required
BS/BA in Computer Science or related field required (or equivalent work experience)
5+ years industrial experience, preferably in a GxP regulated environment
Knowledge of 21 CFR Part 11
Must maintain excellent working knowledge of pharmaceutical regulations (e.g. cGMP's, 21 CFR Part 11, Computers Systems FDA) and other applicable regulations (e.g. Privacy, OSHA, etc.) related to laboratory environment and system applications
Experience with managing external (vendor, consultant) business partners
Minimum of 3+years of experience in the pharmaceutical or biotechnology industry
5+ years of experience with supporting IT Foundational areas such as Virtual environments, Storage area networks, Active Directory\GPOs, Backups, Datacenter Management, Business applications
5+ years of advanced Windows Administration Support and Powershell
Ability to work on multiple concurrent project initiatives
Application administration\troubleshooting experience
Preferred
Effective problem-solving and analytical skills to resolve operational problems
Experience with administration of stand-alone and/or client/server systems
Working knowledge of regulations (GxP) related to system applications
Excellent teamwork and communication (both oral and written) skills
Ability to learn and apply new software tools with agility, when required to complete project assignments
Oral and written communication skills with the ability to develop and present both business and technical presentations is a must
Ability to take initiative, be assertive, lead by example and build high-quality relationships
Strong analytical skills and understanding of server architecture and design
Highly flexible, adapting to changes in priorities, requirements and processes is required
Benefits
Paid time off (holidays, vacation, and additional leave)
Medical, dental, and vision insurance
Life insurance
A company-matched retirement savings plan
Wellness programs
Short- and long-term disability benefits
Company
Celltrion Inc
Celltrion is a fully integrated biopharmaceutical company dedicated to delivering innovative and affordable medications to improve patients’ access to advanced therapies.
1001-5000 employees
H1B Sponsorship
Celltrion Inc has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2023 (1)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
unknown2023-08-17Acquired
2017-07-28IPO
Recent News
2025-12-31
Company data provided by crunchbase