Celltrion Inc · 4 hours ago
IT Business Systems Integrator - Engineering
Branchburg, NJ
Full-time
Hybrid
Senior Level
$118K/yr - $158K/yr
5+ years expCelltrion Inc is a company focused on delivering and supporting products and solutions that drive business value. The IT Business Systems Integrator will identify systems requirements, recommend enhancements, and collaborate with global IT teams to optimize technology solutions while ensuring compliance with relevant regulations.
Health CarePharmaceutical
Responsibilities
Create, modify, and enhance applications and systems to satisfy business information demands. Facilitate changes by delivering feedback from customers to application teams and communicate any changes applied ensuring operational procedures stay current and relevant
Assure adherence of applicable regulatory (i.e. cGXP, CFR, etc.) practices during execution of all work activities. Participate in audits, inspections, and associated readiness activities
Must serve as a technical expert and work with business to identify and capture new opportunities, improve processes, and optimize the value it can provide
Ensure that the technology solutions being implemented are compliant with all relevant regulations (i.e. 21 CFR Part 11, Sarbanes Oxley, GxP, privacy data practices, local and corporate policies)
Provide IT technical and/or validation direction related to computer system Change Management initiatives, as well as the selection, implementation, and upgrade of computerized systems
Identify, recommend, and implement automated solutions to address operations. Execute with precision, speed, and simplicity, ensuring compliance with Computer Systems Validation policies, standards, procedures, and practices. Train and assist business users in proper use of applications and computerized systems
Act as lead investigator for issues deemed to have a system root cause, working with Technical SMEs, functional area SMEs and vendors to identify solutions
Foster professional and inclusive behavior, invite new ideas and differing perspectives among team members, assuring an on-going positive relationship with the customers and other members of the IT organization. Inspire and recognize teamwork
Serve as a technical liaison between local and corporate systems groups, cross-functional or cross-site teams, as requested, interfacing with system owners, IT, QA, Manufacturing, AEG, vendors, and other relevant functional areas. Build enterprise and cross-site connections to ensure integration and results
Stay active and current in business technology trends, direction and innovation related to business process and technology areas of focus by participating in external forums, conferences, and other venues as necessary
Ensure compliance to corporate and site policies and procedures to be audit ready, mitigate risk, and follow quality management practices. Support and abide by applicable Celltrion policies as indicated in the Code of Conduct and other company policies and procedures. All corporate compliance training requirements must be met as required and defined
Qualification
Required
BS/BA in Computer Science or related field required (or equivalent work experience)
5+ years IT or equivalent relevant experience
Minimum of 2+ years in the Life Sciences industry
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 and/or manufacturing environment and system applications
Ability to work on multiple concurrent project initiatives
Experience with managing external (vendor, consultant) business partners
Basic understanding of databases (Oracle, SQL, etc.) and operating systems (Windows, etc.)
Preferred
MS/MBA desirable
Previous experience in a regulated environment preferred
Effective problem-solving and analytical skills to resolve operational problems
Excellent written and verbal communication skills with the ability to develop and present both business and technical presentations
Ability to build relationships across dimensions of difference, ask questions and invite others to contribute
Demonstrated business acumen
Speak up with ideas, concerns and to ensure safety of others
Demonstrated learning agility, and ability to think creatively, try new ideas and apply learnings
Highly motivated, enthusiastic to learn and share ideas and solutions effectively with management and colleagues
Strong collaboration with colleagues at all levels
Demonstrate courage and integrity
Demonstrated success in influencing without authority
Strong customer service and teamwork oriented
Ability to take initiative, to be assertive, to lead by example and to build high-quality relationships
Highly flexible, adapting to changes in priorities, requirements and processes is required
Working knowledge in the following systems is a plus: Maximo, GECMS(Meridian), Genetec
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