IT Computer System Validation Engineer

Company: Celltrion Branchburg, LLC
Location: Somerville
Posted on: February 16, 2026

Job Description:

Job Description Job Description Position Brand Description: This role provides computer system validation support for computerized instruments and systems, including applications and analytics as necessary. Assists in the selection, implementation, and maintenance of computerized systems. Develops and reviews computer system validation deliverables, including Information and Digital Solution procedures and policies. May serve as technical lead to accelerate delivery of new system implementations and projects and serve as a technical representative on project teams. Deploys and supports systems to meet business, regulatory, safety, data integrity and security needs. Provide technical assistance in the diagnosis and resolution of system issues. Identifies compliance issues related to computerized systems and implements effective resolutions. Requires business area knowledge and computer expertise to provide in-depth validation support for new and existing local applications, computerized instruments, and systems. Key Objectives/Deliverables: 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. Basic Requirements: 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. Additional Preferences: 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 This role is exempt and the anticipated compensation for this role is $71,250 - $95,000 Celltrion Branchburg, LLC offers a comprehensive benefits package that includes paid time off (holidays, vacation, and additional leave), medical, dental, and vision insurance, life insurance, a company-matched retirement savings plan, wellness programs, and short- and long-term disability benefits. This role requires up to 10% travel, on-call availability, and may involve shift work. Hybrid work flexibility may be available based on business needs; relocation assistance is not provided. Celltrion Branchburg, LLC is proud to be Equal Opportunity Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity or expression, national origin, protected veteran status, disability, or any other legally protected status.

Keywords: Celltrion Branchburg, LLC, Union , IT Computer System Validation Engineer, IT / Software / Systems , Somerville, New Jersey