Process Engineer

The Process Engineer will play a key role in ensuring successful manufacture of life‑saving cell therapy products. The primary focus of the Process Engineer will be to support testing and implementation of operational improvements and resolve manufacturing process investigations at the BMS cell therapy GMP manufacturing facilities. The Process Engineer will be part of a team tasked with completing manufacturing support studies, including investigational, process improvement and process characterization studies.

This individual will primarily execute experiments, evaluate data, and draft technical reports.

• Provide remote technical troubleshooting support for manufacturing activities at external manufacturing locations and when needed, provide on‑site technical process support of ongoing manufacturing processes.
• Create and revise technical documentation (e.g. changes controls, SOPs, and batch records).
• Perform deviation investigations and corrective and preventive actions (CAPA) as a technical resource. Author technically challenging deviations and drive them towards closure.
• Provide data collection, interpretation, and analysis on manufacturing and manufacturing support processes. Determine areas of opportunity, shifts and trends, and states of control.
• Collaborate with cross‑functional teams, including the CMO joint process team, Process Development, Manufacturing, Quality Assurance and External Manufacturing.
• Perform process fit‑to‑plant, equipment characterization and scale‑up, process FMEA‑based risk assessment, creation of Process Flow Diagrams and Bill of Materials, review and approval of production Master Batch Records.
• Perform detailed review of Process Development processes and generate technology transfer documents, including process monitoring (manufacturing data analysis, summary, and presentation) and authoring campaign summary reports.
• Develop simulated process models to estimate throughput capacity, resources and inventory levels.
• Execute experiments in the CTTO labs which includes aseptic processing and operation of automated process equipment.

• Required BSc in Biology, Chemical Engineering, or Biochemical Engineering with 1 year of relevant experience in process development or commercial manufacturing.
• Demonstrated ability to effectively work in cross‑functional teams, meet deadlines, and prioritize multiple projects.
• Experience in development and/or characterization of biologics and/or cell therapy manufacturing processes.
• Experience working in a self‑driven, performance/results oriented, fast paced matrix environment.
• Experience or knowledge of creating computer‑based process models using process simulation software.
• Experience or knowledge of statistical analysis using statistical software package.
• Able to creatively manage time and elevate relevant issues to project lead and line management.
• Strong scientific and technical writing.
• Detail oriented with excellent verbal and written communication skills.

Mon‑Fri, but need to be flexible with work schedule as maintenance of cell cultures on weekends (maybe 2 weekends monthly), early mornings, evenings, or holidays is required.

Contract Assignment – This posting is for a contract assignment with ASK Staffing DBA ASK Consulting to provide services to Bristol–Myer‑Squibb. The starting hourly compensation for this assignment is $50–$52.64/hr final compensation and any available benefits will be determined by the employer of record ASK Staffing, Inc.

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