Sr. Specialist, Manufacturing Systems Change and Release Management, MSAT MSEO

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Sr. Specialist, Manufacturing Systems Change and Release Management, MSAT MSEO

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locations

Summit West - NJ - US

time type

Full time

posted on

Posted 11 Days Ago

job requisition id

R1579826

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

.
At Bristol Myers Squibb we are reimagining the future of

Cell Therapy . With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of Cell Therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team.
The

Sr. Specialist, MSAT Manufacturing Systems Engineering and Operations, Change and Release Management

is responsible for executing Change and Release Management initiatives, project plans, implementation strategies, technical and documentation tasks, and supporting verification and testing activities, compliant delivery, and operation of Manufacturing Systems used across clinical and commercial value streams in the manufacture of cell therapy products. The position requires knowledge of Manufacturing Systems, SDLC methodologies, Computer System Validation (CSV), Computer System Assurance (CSA), Data Integrity (ALCOA+), and project management methodologies. The incumbent must be independent, goal-oriented, flexible, able to work efficiently across multiple projects, enthusiastic, and innovative, with a basic understanding of change and release management and critical thinking. Works under the guidance of lead team members.
Responsibilities:
Responsible for technical and operational support for the Manufacturing Systems Change and Release Management activities, including documentation, recipe assessment, and change management tasks.
Responsible for developing, implementing, and maintaining site procedures and policies for Manufacturing Systems lifecycle management, aligning with BMS processes, and delivering and maintaining validated technologies suitable for commercial manufacturing.
Ensure completion of all business and system cutover activities.
Ensuring Recipes/MES are configured for intended use per business requirements and applicable procedures throughout the recipes and MES system lifecycle from design to implementation.
Participates in Technical Designs, Prototypes/Mock-ups, Development, Testing, and Delivery of solutions for Release Cycles and/or new projects within the manufacturing systems stack.
Creates and coordinates the deployment communication plans, including “Go Live” readiness, change management, cutover, and stabilization.
Employs a functional understanding of lifecycle management to identify issues and risks that may put the site manufacturing systems at risk. Responsible for escalation and mitigation of such.
Supports the maintenance of the validated state of Site Manufacturing Systems by ensuring compliance with global and site policies and standards
Work closely with Manufacturing, Quality, Supply Chain, IT, MSAT groups, etc., and serve as applicable Manufacturing System Business Owner.
Work closely with colleagues to ensure alignment of key program activities and milestones for deployment and production releases.
Works closely with business owners to establish and maintain service level expectations across all functions and site manufacturing systems.
Works closely with business owners, IT, Quality, network, and global partners to implement site lifecycle strategies aligned with BMS CSV and GAMP guidance.
Align and contribute to the long-term vision of the site’s applications portfolio roadmap.
Collaboration with Build leads/ key stakeholders to perform activities following BMS’s Software Development Lifecycle (SDLC) framework and processes.
Collaborate across the BMS Cell Therapy Network.
Supports daily operations and enhancements of validated site manufacturing systems.
Supports the creation and delivery of assigned validation documentation (e.g., Validation Plans, Requirements,
Specifications (Design, Functional, Configuration), Test Scripts (IQ/OQ/PQ/UAT), Summary Reports, Trace Matrices,
Standard Operating Procedures, and others.
Responsible for coordinating User Acceptance Testing activities, e.g., Scheduling UAT execution, defect management, and resolution.
Anticipates and prioritizes activities that support quality, service, and cost-effectiveness based on a risk-based approach.
Works closely with operational support and delivery teams to ensure post-production support model and process implementation.
Works closely with Project Managers to develop detailed Project Plans related to lifecycle management tasks and deliverables.
Responsible for leading Change Control creation through implementation as part of the Quality Management System (as assigned).
Performs other tasks as assigned.
Support the change initiatives and the implementation of process improvement initiatives.
Foster strong inter-team relationships to achieve common goals.
Looks beyond the obvious for continuous improvement opportunities on the technical and design aspects of the solutions.
Promotes an environment of continuous quality and improvement of processes, standards, and procedures.
Knowledge & Skills:
Advanced time management skills, including prioritizing and managing expectations in a fast-paced working environment.
Advanced proficiency in Microsoft Word, Excel, and Visio.
Advanced technical writing skills
Intermediate knowledge of GMP manufacturing
Intermediate knowledge of Change Management
Advanced presentation development and delivery skills
Critical reasoning and decision-making skills.
Ability to translate strategy into actions.
Ability to work independently and in cross-functional teams.
Operate effectively and with minimal supervision within a team or independently, performing projects and related duties.
Knowledge of Manufacturing Systems Technologies and Computer Systems Validation with an ability to assess the impact and feasibility of system changes.
Working knowledge of Computer Systems Validation with an ability to author and peer review validation, verification, and operational (SOP) deliverables in

biotechnology/pharmaceutical

or related industries.
Working knowledge of Electronic Batch Records (EBR), Review by Exception (RBE), and MES Recipe object lifecycle management preferred.
Familiarity with MES infrastructure, HP ALM, Electronic Document Management Systems, Change Management Systems, and middleware WebMethods preferred.
Basic Requirements:
Bachelor’s degree.
Three (3) or more years of relevant work experience.
Preferred Requirements:
Bachelor’s degree required in Engineering, Biological/Life Sciences, Chemistry, Biochemistry or related field, or equivalent combination of education and work experience.
Three (3) or more years of relevant work experience required in manufacturing support or related experience in the

biotechnology/pharmaceutical

industry.
Cell Therapy experience preferred. Understanding cell culture, cryopreservation, purification, aseptic processing or lab technique, Packaging, Shop floor quality, batch review, or disposition preferred.
Experience with MES, ERP, LIMS, or other manufacturing boundary systems and technologies preferred.
BMSCART
VETERAN
#LI-Hybrid
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

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