Celltrion Inc · 6 hours ago
IT Quality Control Systems Engineer
Branchburg, NJ
Full-time
Hybrid
Mid Level
$118K/yr - $158K/yr
4+ years expCelltrion Inc is focused on optimizing lab and manufacturing processes through technology. The Quality Control Systems Engineer will design, develop, and maintain software applications to enhance operational efficiency and ensure compliance with quality standards.
Health CarePharmaceutical
Responsibilities
Conduct testing, troubleshooting, and ongoing maintenance of assigned applications to ensure system reliability and accuracy of data
Stay up to date with emerging trends in technologies that support the integration of GMP systems
Ensure documented processes and procedures are in place for all activities to meet quality and compliance standards
Identify, recommend, and implement automated solutions to address QC laboratory or manufacturing 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
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 Lilly policies as indicated in the Lilly Red Book and other company policies and procedures. All corporate compliance training requirements must be met as required and defined
Serve as a liaison between local and corporate systems groups, cross-functional or cross-site teams, as requested, interfacing with system owners, IDS, QC, QA, Manufacturing, AEG, vendors, and other relevant functional areas
Build enterprise and cross-site connections to ensure integration and results
Qualification
Required
Bachelor's degree in software engineering, Computer Science, Computer Engineering, or a related field
Minimum of 4+ years of experience working with lab and/or manufacturing systems. E.g: MES technologies such as Rockwell Automation Pharma Suite, Emerson Syncade, Siemens Camstar, or Werum PAS-X, SmartLab, Empower
Must have strong analytical and problem-solving skills
Must have a strong understanding of GMP processes related to manufacturing and lab applications
Must have excellent communication skills
Experience with 21 CFR Part 11, Sarbanes Oxley, GxP, privacy data practices, local and corporate policies
Experience with GMP system interface technologies (ie EDGE; xml, iot integration, PDF parsing etc..)
Experience with basic programming languages required to export/transform data - E.g.: programming languages such as C++, Java, Python, and SQL
Must understand cybersecurity concepts and best practices related to data and operating system security
Excellent communication and interpersonal skills to build relationships with stakeholders and articulate complex technical concepts
Analytical and problem-solving skills to identify and resolve complex technical issues
Adaptability and flexibility to work in a fast-paced, dynamic environment and manage multiple tasks simultaneously
Preferred
Experience with Computer System Validations is a plus
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