Celltrion Inc · 15 hours ago
IT Computer System Validation Engineer
Branchburg, NJ
Part-time
Hybrid
Entry, Mid Level
$71K/yr - $95K/yr
2+ years expCelltrion Inc is a company that focuses on providing computer system validation support for computerized instruments and systems. The role involves leading validation projects, ensuring compliance with regulations, and providing technical assistance for system issues.
Health CarePharmaceutical
Responsibilities
Perform and lead computer system validation projects related to authoring and executing specifications and validation documentation for local applications, manufacturing and laboratory computerized instruments and systems according to the Celltrion Branchburg, LLC Global Computer Systems Quality policies and practices
Ensure that site Computer System Inventory list is maintained in the IT CMDB and remains current
Author validation protocols, such as Validation Plans, Requirements Specifications, Validation Protocols, Traceability Matrices, Summary Reports, and related Change Controls, ensuring 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)
Review and execute Computer System Validation protocols to ensure compliance and adherence with corporate guidelines procedures, CGMP and ISPE GAMP guidelines and regulations. Requirements related to the business use, data integrity, security, access, safety must be considered
Write risk assessments and applicable test scripts according to GMP and 21 CFR Part 11 compliance guidelines and the Site Validation Master Plan. Prepare validation summary reports for executed protocols. Author security administration and system support standard operating procedures, and audit trail review work instructions as appropriate
Execute with precision, speed, and simplicity, ensuring compliance with Computer Systems Validation policies, standards, procedures, and practices. Work with System Owner(s) to ensure that the initiation and implementation of change control activities are in accordance with site procedures. Facilitate a continuous improvement culture within the business areas supported
Investigate and resolve Deviations, CAPA investigations and other potential data integrity issues. Perform and/or review periodic reviews of qualified computer systems
Responsible for the delivery of all CSV lifecycle deliverables for single and multi-user Computerized Systems
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 IDS organization. Inspire and recognize teamwork
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 Branchburg, LLC policies as indicated in the Celltrion Branchburg, LLC Employee Handbook 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)
2+ 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 validation of stand-alone and client/server systems
Basic understanding of databases (Oracle, SQL, etc.) and operating systems (Windows, etc.)
Experience with managing external (vendor, consultant) business partners
Preferred
MS/MBA preferred; experience in a regulated environment a plus
Strong analytical and problem-solving skills
Excellent written and verbal communication; able to present business and technical content
Demonstrated business acumen and learning agility; creative, adaptable, and open to new ideas
Collaborative, relationship-driven, and customer-focused; effective across all levels
Proven ability to influence without authority; shows initiative, integrity, and leads by example
Comfortable speaking up on ideas, concerns, and safety
Flexible and able to adapt to changing priorities and processes
Working knowledge of TrackWise, ServiceNow, Empower, MODA, LIMS, HP ALM, and other laboratory/analytical systems preferred
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
Funding
Current Stage
Public CompanyTotal Funding
unknown2023-08-17Acquired
2017-07-28IPO
Recent News
2025-12-31
Company data provided by crunchbase