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Senior Specialist
Engineer II
Posted on 8/23/2022
Summit, NJ, USA
Experience Level
Desired Skills
Development Operations (DevOps)
  • Knowledge of cGMPs and multi-national biopharmaceutical regulations. Cell therapy experience is a major plus
  • Knowledge of the relationship between manufacturing processes, ERP, and MES a major plus
  • Must have excellent organization skills and ability to handle multiple tasks
  • Hands-on experience with single-use technologies, closed systems, and cold chain/cryogenic technologies
  • Possess strong verbal/written communication skills
  • Ability to think strategically and to translate strategy into actions
  • Bachelors Degree required (science or engineering is preferred) with 3+ years of relevant experience
  • Provide on the floor process support for ongoing manufacturing activities when needed
  • Lead deviation investigations utilizing root cause analysis tools
  • Develop inputs into electronic batch record/process automation technologies to advance digital manufacturing strategy
  • 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 in accordance with business requirements and applicable procedures throughout the recipes and MES system lifecycle from design to implementation
  • Translate business requirements into functional and design specifications which is compliant, efficient, and effective
  • Participate on project teams to help prepare project 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
  • Foster strong inter-team relationships to achieve common project goals
  • Interface with operations and serve as process SME
  • Support monitoring, analyzing, and optimizing the end-to-end process and anticipate and permanently resolve issues that may arise during production
  • Execute test plans and other risk mitigation exercises as part of investigations (e.g. Root cause analysis and CAPAs)
  • Organize, record and maintain experimental data
  • Stay current with industry trends and standards (e.g. PDA, ISPE) and participate in best practice forums consistent with function responsibilities
  • Assist with revisions of the content of technical documentation (e.g. investigations, changes, SOPs and batch records)
  • Interact with other teams including Validation, Development, Operations, QA and Regulatory
  • Participate in routine plant operating meetings
  • Proven ability to accurately and completely understand, follow, interpret, and apply Global Regulatory and cGMP requirements
  • Support health authority inspections
  • Ability to set priorities, manage timelines and effectively react/manage changing priorities
  • Ability to work with management (global and site) and support corporate and departmental goals
  • Ability to communicate honestly, transparently, and effectively with peers, department management and cross functional peers
  • Hands on experience preferred with CAR T or biopharmaceutical manufacturing and Quality Control. Proven delivery of complex investigation reports
  • Ability to train and mentor junior associates to foster and develop their expertise
Bristol-Myers Squibb

10,001+ employees

Biopharmaceutical development company
Company Overview
Bristol-Myers Squibb engages in the discovery, development, licensing, manufacturing, marketing, distribution and sale of pharmaceuticals.