Job Description
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. 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.
The Sr. 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: Knowledge, Skills, and Abilities: - 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 - 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 weekends on a rotation basis.
- Support daily operation and future enhancements of Syncade MES and other Manufacturing systems as an IT system owner and technical expert.
- Support integration initiatives between site manufacturing systems and above-site, enterprise systems, e.g., LIMS, ERP, RTMS, etc.
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as "Transforming patients' lives through science™ ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to
[email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information:
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. Bristol-Myers Squibb Company
Job Tags
Remote job, Shift work, Weekend work,