Senior Compliance Expert Control Deviations CAPA

Overview

The Specialist I, Associate Engineer is responsible for supporting the production of personalized cell therapy products for global clinical trials and commercial supply at the Bristol Myers Squibb Cell Therapy Manufacturing Plant in Bothell, WA. The Associate Engineer will join the Cell Therapy Lifecycle Management team under the Bothell Manufacturing Sciences and Technology (MSAT) department. The Associate Engineer is expected to be a process subject matter expert for all manufacturing platforms at the BMS Manufacturing facility in Bothell.

The Associate Engineer will be responsible for the implementation of cell therapy manufacturing technologies, including cross-departmental collaboration to enable facility fit, development of process documentation (Batch Records, Forms, etc), E-Systems deployment, inspection readiness, and training. The Associate Engineer will support product and manufacturing facility lifecycle management, including commercialization and evolution of cell therapy products as well as changes required to enable flexibility in use of the manufacturing areas.

The Associate Engineer will ensure the completion of all deliverables, critical to maintain production and supply redundancy. This work heavily involves the use and management of quality records and stakeholder relationships with Quality Assurance, Cell Therapy Technical Operations, Manufacturing, Supply Chain, Facilities and Engineering, and Project Management organizations, and collaboration with other cell therapy sites within the BMS network.

• Education
  :
  Bachelor’s Degree in life sciences/engineering or equivalent.
• Experience:
  
  3 years of relevant experience in the cell therapy industry with a BS, or 2 years of relevant experience with a MS.
• Ability to effectively work in cross‑functional teams, meet deadlines as an individual contributor, and prioritize responsibilities.
• Experience working in a self‑driven, performance/results oriented, fast‑paced matrix environment.

• Quickly and thoroughly learns cell therapy processes and equipment involved.
• Owner and impact assessor of change controls for process and procedure changes.
• Owner of change controls for complex manufacturing and manufacturing facility changes.
• Functions as a technology and process subject‑matter expert.
• Applies continuous improvement tools to identify opportunities for process improvements and operational efficiencies, and leads implementation efforts.
• Follows change‑management SOPs, standards, policies and directives, delivering a consistent flow of ongoing support production. Some measurable tactical achievements and 360 feedback indicative of confidence in ability to lead initiatives of limited scope.
• Represents MSAT and interfaces with other functions such as Cell Therapy Technical Operations, Supply Chain, Quality, Manufacturing, F&E, and Project Management.
• Quickly learns from others and consistently steps up proactively. With some frequency, proactively supports other team members and helps them to be successful.
• Routinely seeks opportunities to learn BMS values. Excels in demonstrating one of the BMS values—Integrity, Innovation, Passion, Urgency, Inclusion, Accountability—and works to address perceived deficiencies.
• Supports the completion of quality records (change controls, deviations, Corrective and Preventative Actions), GMP training, and continuous improvement initiatives.

• Normal office environments, GMP‑controlled cleanroom in the context of approved gowning and cleaning procedures, and handling of equipment.
• This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
• This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to…