- Engage with Site teams (Manufacturing, Quality, Supply Chain, Shared Services, etc.) to support and improve capacity, quality, and cost or to establish root cause.
- Work closely with end users/process owners and subject matter experts to maintain service level expectations across all functions and site systems.
- Work with site functional teams, including manufacturing, engineering, warehouse, and quality assurance to gather user requirements for recipe development.
- Provide on-the-floor or remote process support for ongoing manufacturing activities when needed.
- Participate in delivering critical improvements across the manufacturing network through digital technology (e.g., EBR) updates and technical insight.
- Provide MES product impact assessments to support change management, investigations, and product release.
- Develop inputs into electronic batch record/process automation technologies to advance digital manufacturing strategy.
- Lead or assist in designing, testing, and maintaining Electronic Batch Records and related manufacturing data, including, but not limited to, specifications, process parameters, recipes, routings, formulas, process instructions, and process variables.
- 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.
- Support lifecycle management project implementation at a site level to accomplish drug product harmonization across sites and evolve the process.
- Translate business requirements into functional and design specifications that are compliant, efficient, and effective.
- Participate in project teams to help prepare schedules, execute technical projects, and develop presentations to disseminate results to project stakeholders and senior management.
- Interface with Manufacturing, Quality, Supply Chain, IT, MSAT groups, etc., and serve as applicable Manufacturing System Business Owner.
- Perform process monitoring initiatives, including but not limited to developing and collecting data, analyzing and optimizing the end-to-end process, and anticipating and permanently resolving issues that may arise during production.
- Continuously integrates with the business to understand current business processes and to provide technology guidance that enables and supports Digital Plant plans and strategies.
- Support Technical Product Team, Validation, Development, Operations, QA, and Regulatory in the area of expertise. Knowledge & Skills:
- Ability to communicate honestly, transparently, and effectively with peers, department management, and cross-functionally.
- Ability to build and leverage cross-functional relationships to bring together ideas, data, and insights to drive continuous improvement and strong partnerships across functions.
- Intermediate knowledge of manufacturing execution systems and ERP systems. Knowledge of the relationship between manufacturing processes, ERP, and MES preferred.
- Intermediate knowledge of SQL, VBA, and/or XML preferred.
- Intermediate technical writing skills.
- Working knowledge of cGMP regulations. Cell therapy experience is preferred. Ability to accurately and completely understand, follow, interpret, and apply Global Regulatory and cGMP requirements.
- Working knowledge of Electronic Batch Records (EBR), Review by Exception (RBE), and MES Recipe object lifecycle management preferred.
- Working knowledge of HP ALM, Electronic Document Management Systems, and Change Management Systems preferred.
- Experience with single-use technologies, closed systems, cold chain/cryogenic technologies, Packaging, Shop floor quality, batch review, or disposition is preferred. Cell therapy experience is preferred.
- Basic/Intermediate knowledge of Deviation and Change Management.
- Ability to provide on-call support in case of emergent issues. Basic Requirements:
- Bachelor's degree
- 2 or more years of relevant work experience in cGMP environment Preferred Requirements:
- Bachelor's degree in Engineering, Biological/Life Sciences, Chemistry, Biochemistry or related field
- 2 or more years of relevant work experience required, preferably in a pharmaceutical manufacturing environment
- 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. Working Conditions:
- The incumbent will work in an office environment, potentially requiring ergonomic considerations.
- The incumbent will be required to work in a conference room environment for moderate periods.
- The incumbent will be required to work in the manufacturing labs, production areas, or warehouses requiring gowning.
- The incumbent may travel between company sites for training, meetings, or corporate events on occasion.
- The incumbent will be expected to work non-standard work hours, including weekends and/or holidays, to support high-priority project deadlines or emergency efforts impacting delivery. If you want to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients' lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today.
BMSCART
#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 . Visit 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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Specialist, Manufacturing Systems Engineer, MS&T MSEO - Summit, United States - Bristol Myers Squibb Company
Description
Working with UsChallenging. 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: .
Cell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today. With therapies only in their infancy and BMS's continued investment in our Cell Therapy capabilities, the growth potential of this science, your career, and the ability to help patients are incredible.
The Specialist, Manufacturing Systems Engineer , MS&T MSEO is responsible for supporting the solution intake and design, delivery, operational support, continuous improvement, change management, and lifecycle for the site manufacturing execution system (MES) and associated boundary systems used in the production of personalized cell therapy products for both global clinical trials and commercial supply.
Responsibilities:
