Principal Engineer - Seattle, WA

Job Description ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post. 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. Title: Principal Engineer, OEM Technology Development & Integration Lead Location: Seattle, WA 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. We are seeking a Principal Engineer to lead the design, development and integration of bespoke cell therapy production technologies in efforts to advance next generation cell therapy manufacturing. The OEM Technology Development & Integration Lead will leverage their expertise in cell therapy operations and GMP system design to actively shape, define and lead the ideation and development of industrial cell therapy production technologies and ensure process and analytical integration within BMS' manufacturing platform. Specifically, the OEM Technology Development & Integration Lead will systematically evaluate the current state of BMS' cell therapy production, in conjunction with our process constraints, and create and execute a design and development strategy to attain highly robust and reliable production systems, in collaboration with internal and external partners. 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 & 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 & system reliability program/champaign for equipment systems to achieve high-capacity and autonomous cell therapy production. This includes 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. Additional Qualifications/Responsibilities Qualifications & 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. If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. The starting compensation for this job is a range from $127,000 - $159,000, plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location.

Created: 2024-11-02