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Senior Specialist
Process Engineer II
Posted on 7/6/2022
INACTIVE
Locations
Summit, NJ, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Data Analysis
Development Operations (DevOps)
Management
Requirements
  • Knowledge of cGMP's and multi-national biopharmaceutical regulations. Cell therapy experience is a major plus
  • Deep knowledge of facility/clean room design, process, equipment, automation, and validation
  • Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities
  • Hands-on experience with single-use technologies, closed systems, and cold chain/cryogenic technologies
  • Experience working with external parties and/or leading cross-functional teams
  • Possess strong verbal/written communication skills and ability to influence at all levels
  • Ability to think strategically and to translate strategy into actions
  • Ability to prioritize and provide clear direction to team members in a highly dynamic environment
  • Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities
  • Bachelor's Degree in science or engineering (advanced degree is preferred)
  • 3 or more years of manufacturing support or related experience in the biopharmaceutical industry
Responsibilities
  • Participate on project teams to prepare project schedules, coordinate the execution of technical projects and develop presentations to disseminate results to project stakeholders and senior management
  • Run internal projects (e.g. Project initiation, planning, scope, funding requests, approvals, execution and closeout)
  • Work closely with Engineering /Maintenance on the design and implementation of new technology and new systems/facilities related to production process needs
  • Interface with operations and serve as process SME. Learn the procedures, analytics and document any known sensitivity
  • Support monitoring, analyzing, and optimizing the end-to-end process and anticipate and permanently resolve issues that may arise during production
  • Support inspection readiness and actively support regulatory inspections and ensure safe and compliant cGMP operations
  • Review and revise the content of technical documentation (e.g. investigations, changes, SOPs and batch records)
  • Interact with other teams including Validation, Development, Operations, QA and Regulatory
  • Support Director in accomplishing productivity and financial goals with the cross-functional team
  • Participate in routine plant operating meetings
  • S12 is a 24/7 CAR T manufacturing site and this position may require night / weekend rotational work hours
Bristol-Myers Squibb

10,001+ employees

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