Principal Engineer, OEM Technology Development and Integration Specialist

2 weeks ago

Seattle, Washington, United States Bristol-Myers Squibb Full time
Job Summary

We are seeking a highly skilled Principal Engineer to lead the design, development, and integration of bespoke cell therapy production technologies in efforts to advance next-generation cell therapy manufacturing.

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.
  • Develop a comprehensive equipment and system reliability program to achieve high-capacity and autonomous cell therapy production, including the creation of a comprehensive Process and Equipment FMEA, OEM technology design integrations against known system failure modes, creation of auto-recovery methods, and systematic characterization of OEM system robustness.
  • Creation of internal service and maintenance strategy and executable plan associated with OEM technologies to minimize system downtime and recovery.
  • Lead supplier interfaces and manage external relationships in efforts to drive innovation and successfully execute on project deliverables.
Qualifications and Experience:
  • 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 cell and gene therapy technology development preferred.
  • Experience in developing and implementing automated technologies and/or automation systems into GMP manufacturing. DeltaV automation expertise is preferred.
  • 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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