Specialist IT, Cell Therapy Manufacturing Systems

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

PURPOSE AND SCOPE OF POSITION

The Specialist IT, Cell Therapy Manufacturing Systems, plays a crucial role in supporting the seamless operation of manufacturing and business functions at Summit, Cell Therapy Site. This position involves interaction with internal team members, peers, higher-level customers, and external service providers. The individual is responsible for developing and adhering to system governance procedures and supporting multiple IT projects and ongoing work activities of moderate to high complexity. The individual will address IT issues for manufacturing and support staff. This role necessitates that the candidate be on-site at Summit, New Jersey, for at least 50% of the time.

Reporting to the IT organization, the candidate will drive solutions to manufacturing system-related problems, including building, testing, documenting, and implementing design changes.

REQUIRED COMPETENCIES

• Effective communication with both technical and non-technical team members.
• Strong interpersonal skills, particularly in teamwork, collaboration, and verbal and written communication.
• Knowledge of cGXP, GAMP, SDLC regulations, including 21 CFR part 11, and good documentation practices.
• Understanding of pharmaceutical, manufacturing and equipment supporting Cell Therapy Commercial and clinical manufacturing.
• Strong technical and problem-solving skills, with the ability to work independently.
• Proven success in a high-performing, business results-driven environment.
• Clear understanding of the change management process, including writing change controls.
• Ability to work as part of a cross-functional technical team to ensure successful system and technology implementation.
• Ability to troubleshoot, design, and build application integrations that support critical manufacturing processes.

BASIC QUALIFICATIONS

• 0-2+ years of experience in pharma/biotech projects, focusing on Manufacturing and IT disciplines.
• Knowledge of shop floor activities, Good Manufacturing Practices (GMPs), and process automation.
• Prior experience in Manufacturing Execution System (MES) and support, preferably Syncade MES.
• Bachelor’s degree in Chemical, Mechanical, Biomedical, Electrical or Computer Engineering, or MIS discipline.
• Experience with reporting systems like Informetric InfoBatch.
• Experience with labeling systems like Bartender.
• Experience integrating MES with other enterprise applications like ERP(Oracle/SAP), LIMS, RTMS, etc.
• Ability to author, review, and approve technical documentation, protocols, and reports, including IQ/IQ/PQ protocols, change controls, and SOPs

Preferred Qualifications

• Understanding of Electronic Batch Records (EBR) and Review by Exception (RBE). Recipe Authoring is a plus.
• Experience with Microsoft SQL Server, reporting services, database design, and data architecture. Query creation in multiple database environments.
• Experience with Test Strategy, Test Management, and Defect Tracking Tools like HP ALM.

DUTIES AND RESPONSIBILITIES

• Collaborate with business stakeholders and implementation partners to configure, build, and perform implementations, enhancements and bug fixes using Syncade MES.
• Work with business process leads to design master data, recipes, and define best practices.
• Provide support for operationalizing the manufacturing and peripheral systems.
• Ensure uninterrupted 24/7 operation of manufacturing systems for CAR T manufacturing, including on-call support on weeke