Job Details

Senior Specialist IT, Cell Therapy Manufacturing Systems

Information Technology

icon-location-marker Summit West - NJ - US
Posted Yesterday Full_time R1583960

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:

Sr.Specialist IT, Cell Therapy Manufacturing Systems supports the successful operation of manufacturing and business functions at multiuse sites through interaction with internal team members, peer, and higher-level customers as well as external service providers. The individual is responsible for development of and adherence to system governance procedures. The individual supports multiple IT projects/systems and ongoing work activities of moderate to high complexity. The individual will answer questions and resolve IT issues for manufacturing and manufacturing support staff.  This is primarily an onsite position
 

Reporting into the IT organization the candidate will be primarily responsible for driving solutions to manufacturing system related problems including building, testing, documenting, and implementing design changes.
 

The candidate should have at least 3 years of experience in pharma/biotech projects with specific expertise in Supply Chain, Manufacturing, and IT disciplines. The candidate must have knowledge of shop floor activities, Good Manufacturing Practices (GMPs), and process automation in addition to prior experience in Manufacturing Execution System (MES) use and support. 

REQUIRED COMPETENCIES:  Knowledge, Skills, and Abilities:

  • Ability to effectively communicate with both technical and non-technical team members.
  • Strong interpersonal skills, especially regarding:
    • Teamwork and collaboration
    • Client focus
    • Verbal and written communication
  • Knowledge of cGXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices.
  • Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment that support Biologics and clinical manufacturing.
  • Strong technical and problem-solving skills, strong verbal and written communication skills, and the ability to work independently.
  • Demonstrated success working in a high-performing, business results-driven environment.
  • Understanding of computer system validation. Ability to write IQ/OQ scripts.
  • Clear understanding of the change management process. Ability to write change controls.
  • Work as part of a cross-functional technical team to ensure a successful implementation of systems and technology
  • Work with business units, application developers, security, and infrastructure engineering to troubleshoot, design and build application integrations that support critical manufacturing processes.

BASIC QUALIFICATIONS

  • Bachelor’s Degree in Chemical, Mechanical, Biomedical, Electrical or Computer engineering or MIS discipline is required.
  • Must have 4+ years of hands-on experience in a Pharma/Biotech manufacturing and supply chain environment.
  • Must have experience with Manufacturing Execution System Design and Support, preferably RTMS, Emerson Syncade, Informetric InfoBatch, OSIsoft PI Historian and/or Emerson DeltaV, in a Pharma/Bio-tech manufacturing environment.
  • Experience in scheduling applications. Sound understanding of model development & creation. 
  • Experience in integrating manufacturing systems (ERP, MES, LIMS, RTMS)
  • Understanding of supply chain, manufacturing domains, and supporting technology including manufacturing and supply chain ERP systems (e.g. Oracle, SAP).
  • Working knowledge of regulatory requirements and how they relate to existing and new business systems and practices, primarily cGxP.
  • Must have prior experience working on a project team to implement, customize, or enhance Manufacturing system.
  • Author, review, and approve technical documentation, protocols, and reports. This includes but is not limited to IQ/IQ/PQ protocols, change controls, and SOP

Preferred Qualifications

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

DUTIES AND RESPONSIBILITIES:

  • Collaborate with business stakeholders and implementation partner(s) to configure, build, and deploy the RTMS and MES systems.
  • Collaborate with business process leads to design master data, recipes, etc., and define best practices.
  • Provide support for operationalizing the manufacturing and peripheral systems.
  • Accountable for uninterrupted 24/7 operation of manufacturing systems for CAR T manufacturing.
  • Support daily operation and future enhancements of 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 an inclusive culture, promoting diversity 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 a diverse 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 adastaffingsupport@bms.com. 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.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.