Job Description

At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through science. In oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Position Title:

Sr. Specialist, System Documentation (ERP & MES)

Location:

Summit West, S 12

Shift:

Sunday - Wednesday 4/10 Compressed Work Schedule

Division

CTDO Material Management

Direct Manager

Sr Director, CAR-T Supply Chain

Grade

D05

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

PURPOSE AND SCOPE OF POSITION:

The Sr. Specialist, System Documentation is responsible for the development of MES and ERP related documentation, system change management, on-site technical support, troubleshooting and problem resolution for the site manufacturing execution system (MES) and Enterprise Resource Planning (ERP) system. Specialists work with IT, manufacturing, engineering, vendors, and resources supporting boundary systems to deliver documentation changes for MES recipes. The position requires strong project management skills and coordination with stakeholders. The position works under the guidance of lead team members. The Process & Technology department supports both the Summit S12 and Warren sites for cellular therapy manufacturing at Bristol-Myers

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

* Advanced time management skills, including ability to prioritize and manage expectations
* Advanced proficiency in Microsoft Excel & Visio
* Advanced technical writing skills
* Intermediate knowledge of qualification and validation requirements in a regulated environment
* Intermediate knowledge of GMP manufacturing
* Intermediate knowledge of crystal report design
* Basic presentation development and delivery skills
* Basic knowledge of cGMP regulations
* Ability to provide accurate estimates and effectively communicate status of deliverables
* Ability to gown into Grade C and D classified environments
* Ability to provide on-call support in case of emergent issues
* Ability to travel < 10% of time
* Ability to work independently for extended periods of time
* Ability to work in a collaborative environment
*
Education and Experience:

* Bachelors degree in a related field from an accredited college or university required.
* Minimum of 5 years relevant work experience required, preferably in a pharmaceutical manufacturing environment.
* An equivalent combination of education, experience and training may substitute.

DUTIES AND RESPONSIBILITIES:

* Responsible for providing manufacturing execution system operational support, documentation, and change management.
* Develop Recipe Functional Specifications for MES electronic batch record (EBR) recipes based on Master Batch Record requirements and Recipe design.
* Develop documentation to support the qualification of the MES recipes, including test scripts, UAT Plans, and UAT Summary Reports.
* Initiate and manage Change Controls in Quality Management System for Recipe Releases.
* Manage User Acceptance Testing process for recipe qualification.
* Adhere to GxP regulatory requirements and internal procedures.
* Provide technical support by troubleshooting and resolving MES and ERP issues to support manufacturing operations.
* Assist with department support model, including 12x7 on-call support rotation.

WORKING CONDITIONS (US Only):

The incumbent will be required to gown to access classified manufacturing areas.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

BMSCART

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.