Principal Engineer, QC Automation, Cell Therapy

Working with Us
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. 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. Read more: careers.bms.com/working-with-us.

Position Summary:

Subject matter expert leading implementation of state-of-art automation solutions for QC bioanalytical methods and technologies in autologous and allogenic cell therapy programs. Work collaboratively with internal and external stakeholders to ensure automation designs meet compliance and business requirements. Build effective relationships/partnerships and work cross-functionally with internal and external stakeholders to implement novel integrated automated systems to streamline execution and analysis of cell therapy assays. Perform all functions related to automation technical transfer into the QC lab, including documentation associated with requirements gathering, development, IQ/OQ/PQ, and test method validation. Apply technical knowledge, regulatory requirements, and scientific principles to independently perform complex troubleshooting and problem solving.

Duties/Responsibilities:

• Site lead and subject matter expert for QC automation systems, supporting the design and development of partial and integrated automation platforms for bioanalytical methods. Lead site implementation of automation systems into the GMP QC laboratory. 
• Work with internal automation development team and external integration vendors to establish end-to-end integrated analytical automation platforms for GMP QC labs.
• Work collaboratively with internal and external stakeholders to ensure automation designs meet compliance and business requirements.
• Perform all functions related to automation technical transfer into QC lab, including documentation associated with requirements gathering, development, IQ/OQ/PQ, and test method validation.
• SME for training and mentoring QC team on automation methods, processes, and procedures.
• Independently develop, write, and execute analytical automation protocols, reports, and other related documents aligned with regulatory and corporate guidelines.
• Represent the department in product review boards, regulatory inspections (internal and external audits). Own and author responses to regulatory requests.
• Review and approve laboratory investigations.
• Champion and foster a positive and successful collaborative quality culture.
• Conceptualize and lead complex projects, CAPAs, deviations, and continuous improvement efforts. Optimize automated systems, expand capabilities, and support technical investigations.
• Represent QC interest on cross functional/ cross-site teams and communicate and collaborate effectively.
• Apply technical knowledge, regulatory requirements, and scientific principles to perform troubleshooting and problem solving for non-routine complex issues.
• Perform other tasks as assigned.

Specific Knowledge, Skills, Abilities:

• Advanced ability to accurately and completely understand, follow, interpret and apply global regulatory and cGMP requirements.
• Demonstrated advanced technical writing skills.
• Advanced strategic thinking and problem-solving ability/mentality, technically adept and logical.
• Ability to work independently in a fast-paced team environment, meet deadlines, and prioritize work from multiple projects.
• Advanced ability to communicate and collaborate effectively with peers, senior management and cross-functional peers about task status, roadblocks and needs, locally and globally.
• Advanced mentoring, coaching, influencing, negotiating and personnel interaction skills.

Education/Experience/ Licenses/Certifications:

• Bachelor’s degree or equivalent required, preferably in engineering, computer science, chemistry, or biology. Advance