Senior Validation Engineer I (Aseptic Processing & Environmental Controls)

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

Position Summary

The Senior Engineer I, Validation is responsible for supporting the production of personalized cell therapy products for clinical and commercial supply at the BMS Manufacturing Plant (Jump), in Bothell, WA. The Senior Engineer I, Validation is responsible for ensuring the compliance of aseptic processes and environmental control systems. The Senior Engineer I, Validation supports airflow visualization study (AVS), aseptic process simulation (APS), cleanroom reclassification (CRC), environmental monitoring performance qualification (EMPQ), and non-routine simulation (NRS) programs as a member of the Jump Manufacturing Sciences and Technology (MSAT) department. This role involves developing and executing validation protocols, as well as providing technical expertise and guidance to ensure the highest level of quality and regulatory compliance to ensure patient safety and implement best in class practices.

Duties/Responsibilities

• Develops and executes validation plan for cGMP critical equipment and system with validation document deliverable in respect to cGMP, GDP, GXP, including 21CFR Part 11, , EU GMP Annex 1 principles.
• Acts as a validation Subject Matter Expert (SME) providing support to multi-function teams, advises operations on validation matters, and potentially serves as the point of contact to present validation programs and strategies and defend their work before Health Authority inspectors and auditors.
• Develop, execute, and report on APS, AVS, CRC, EMPQ, and NRS aseptic and environmental control activities and manage requalification schedule for routine APS and CRC
• Plan APS, AVS, CRC, EMPQ, and NRS aseptic and environmental control activities and coordinate cross-functional teams comprised of Materials Management, Manufacturing, Patient Services, Scheduling, Quality Assurance, Quality Control, and Validation
• Investigate and resolve deviations and non-conformances with oversight from Validation and Quality Assurance leadership
• Maintain accurate and up-to-date validation documentation, including protocols, reports, and standard operating procedures (SOPs), in compliance with regulatory standards
• Develop and manage electronic validation documentation such as risk assessments, protocols, studies, and reports using the ValGenesis validation lifecycle information management system
• Serve as a subject matter expert for aseptic and environmental control programs
• Support quality record processing through assisting in impact assessments and owning action items
• Provide oversight, training, and support to APS, AVS, CRC, EMPQ, and NRS participants during aseptic and environmental control activities
• Support cross-functional efforts to ensure regulatory compliance and protect patient safety
• Follow validation regulations, policies, standards, procedures, and work instructions
• Provide strong technical knowledge of cellular therapy systems, materials, equipment, and aseptic processing techniques
• Provide technical input and investigation support for production related investigations to maintain the validated state of the aseptic process
• Stay current with industry standards and participate in best practice forums consistent with function responsibilities
• Work collaboratively with peers within the cross-functional teams (F&E, IT, MFG, QC, Supply Chain, and QA/QEV) to manage workload to address priorities, meet schedules, maximize productivity, reduce costs and COGM, and increase efficiencies.
• With minimal supervision, executes validation projects and tasks assigned and occasionally leads one or more projects within the validation area and contributes to more complex projects and initiatives for the broader site.
• Quickly learns from others and consistently steps up proactively. With some