Celltrion Inc · 1 week ago
Engineer - TS/MS Process Data
Branchburg, NJ
Full-time
Hybrid
New Grad, Entry Level
$72K/yr - $96K/yrCelltrion Inc is a company focused on manufacturing and quality assurance in the biotechnology sector, and they are seeking an Engineer for TS/MS Process Data. The role involves data analysis support for manufacturing processes, ensuring data accuracy, and maintaining databases to support production and regulatory documentation.
Health CarePharmaceutical
Responsibilities
Verifies the accuracy of the data entered into the in-process database and ensures that all of the data entries are complete
Creates and maintains data entry forms for use by manufacturing staff, providing training as necessary on data entry procedures. Anticipates customer needs and handles nonstandard requests
Ensures the data structure remains consistent with process changes that may occur; reviews batch records as necessary to ensure that data is recorded consistently for different products. Requires technical knowledge within discipline
Assists with the monitoring (trending) and analysis of manufacturing production data to support: process monitoring, process deviations, process validation, technology transfer documentation, BLA filings, annual manufacturing summaries for regulatory documentation, etc
Assists with the maintenance and troubleshooting of the manufacturing in-process database while providing sound problem-solving skills to complex issues, as applicable
Provides in-process data for technical reports supporting technology transfers, deviation/adverse event reporting and process analysis/trending. May be asked to author or provide content for some technical reports. Educates self and others on complex issues and gains support for ideas
Contributes to in cross-site data sharing initiatives
When requested, provides in-process data for technical reports supporting technology transfers, deviation/adverse event reporting and process analysis/trending
May participate / lead projects or programs with various levels of risks. Makes decisions that impact own priorities and allocation of time to meet deadlines
Provides sound problem solving skills to complex issues
Writes SOPs as they relate to the activities of the TS/MS group. May assist with SOPs from other manufacturing groups
Understands and performs all job responsibilities in compliance with safety and regulatory expectations, as well as cGMP
Qualification
Required
B.S. in a scientific discipline or equivalent skills and relevant experience
Strong mathematical and analytical skills
Word, Excel, and PowerPoint experience required
An understanding of current Good Manufacturing Practices required
Excellent oral and written communication skills
Proficiency with software such as Microsoft Office Suite and JMP
Preferred
SQL database experience a plus
JMP and coding experience a plus
Experience in cell culture and/or protein purification manufacturing a plus
Familiarity with TrackWise and LIMS 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 coverage
Company
Celltrion Inc
Celltrion is a fully integrated biopharmaceutical company dedicated to delivering innovative and affordable medications to improve patients’ access to advanced therapies.
Founded in 1999
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
unknown2023-08-17Acquired
2017-07-28IPO
Recent News
2025-12-31
Company data provided by crunchbase