Principal Engineer, OEM Technology Development and Integration Lead

5 days ago

Seattle, Washington, United States Bristol-Myers Squibb Full time
Job Title: Principal Engineer, OEM Technology Development and Integration Lead

Bristol-Myers Squibb is seeking a highly skilled Principal Engineer to lead the design, development, and integration of bespoke cell therapy production technologies. The successful candidate will leverage their expertise in cell therapy operations and GMP system design to shape, define, and lead the ideation and development of industrial cell therapy production technologies and ensure process and analytical integration within BMS' manufacturing platform.

Key Responsibilities:
  • Leverage a deep understanding of BMS' current state cell therapy technologies, operations, and process constraints to establish and execute a development and automation technical strategy for the creation of highly robust and reliable production systems, in collaboration with key OEMs.
  • Provide technical and project leadership to internal and external stakeholders and partners to drive the development of novel and customized equipment, single-use systems, and automation software for executing process operations unique to cell therapy manufacturing.
  • Oversee the transformation of novel prototype and early development equipment into GMP-ready unit operation platforms in preparation for deployment into clinical and commercial manufacturing operations.
  • Evaluate OEM system configurations and designs, and draft standard GMP equipment project documents, including User Requirement Specifications, Design Specifications, Process and Equipment System FMEA, to inform OEM system designs and tech transfer packages.
  • Lead the evaluation and testing of bespoke prototype and GMP systems to demonstrate suitability for applicable cell therapy processes and integration with BMS' manufacturing platform, in alignment with OEM system and functional requirements.
Requirements:
  • Ph.D. in an engineering field with 4+ years of experience in design and development of process or analytical equipment/systems for biologic, cell, and/or gene therapy products.
  • B.S./M.S. in a scientific or engineering field with 8+ years of process or analytical equipment development experience.
  • Experience in developing and implementing automated technologies and/or automation systems into GMP manufacturing.
  • Strong experimental design skills with hands-on experience with development and operationalization of cell therapy technologies to support end-to-end process applications.
  • Experience drafting standard GMP equipment project documents, including User Requirement Specifications, Design Specifications, FAT Protocols, Installation/Operation Qualification Protocols, Tech Transfer Package.
  • Experience executing equipment of facility qualification protocols (FAT, SAT, IQ, OQ, etc.).
  • Familiarity with GMP biomanufacturing requirements, preferably direct experience working in a GMP environment.
  • Broad knowledge of equipment and pharmaceutical facility industrial standards and guidelines, including ICH Q7, GAMP5, NEMA, UL.
  • Experience drafting, reviewing, and approving equipment systems drawings and designs.
  • Can-do attitude and ability to work in a highly matrixed and dynamic business environment.
  • Deep scientific curiosity and commitment to advancing therapeutic innovation that provides better options for patients.
  • Strong problem-solving and risk-based decision-making skills and a strong ability to influence or manage without direct authority.
  • Highly developed interpersonal, communication, and negotiation skills.
  • Self-motivated individual with demonstrated ability to lead and support highly cross-functional teams.
  • Demonstrated ability to analyze technical data and design experiments.

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