Senior Specialist, Sr. Manufacturing Systems Engineer, MS&T MSEO

at  BristolMyers Squibb

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.
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 Senior Specialist, Sr. 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.

KNOWLEDGE & SKILLS:

• Advanced technical document writing.
• Working knowledge of Electronic Batch Records (EBR), Review by Exception (RBE), and MES Recipe object lifecycle management preferred.
• Experience with HP ALM, Electronic Document Management Systems, and Change Management Systems preferred.
• Knowledge of cGMPs and multi-national biopharmaceutical regulations. Cell therapy experience is preferred.
• Knowledge of the relationship between manufacturing processes, ERP, and MES preferred.
• Experience with single-use technologies, closed systems, and cold chain/cryogenic technologies, Packaging, Shop floor quality, batch review, or disposition is preferred.
• Hands-on experience preferred with CAR T or biopharmaceutical manufacturing and Quality Control.
• Proven delivery of complex investigation reports preferred.
• Ability to train and mentor junior associates to foster and develop their expertise, to coach, develop, delegate, and motivate others.

BASIC REQUIREMENTS:

• Bachelor’s degree required
• 3 or more years of relevant work experience working in a cGMP manufacturing environment

PREFERRED REQUIREMENTS:

• Bachelor’s degree in Engineering, Biological/Life Sciences, Chemistry, Biochemistry or related field, or equivalent combination of education and work experience.
• Advanced degree preferred.
• 3 or more years of relevant work experience required in manufacturing support or related experience in the biotechnology/pharmaceutical industry.
• 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.

• Provide technical direction and expertise across 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.
• 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.
• Support the change initiatives and the implementation of process improvement initiatives.
• Interface with Manufacturing groups, Quality groups, 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.
• Support health authority and internal inspections.