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 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. change 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 Failure Modes and Effects Analysis (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. 100% onsite.

This posting is for a contract assignment with ASK Staffing DBA ASK Consulting to provide services to Bristol Myer‑Squibb.

ASK Consulting provides comprehensive, ACA‑compliant health coverage, along with dental, vision, short‑ and long‑term disability for eligible employees. We also offer commuter benefits, a 401(k) plan with no matching, and a referral bonus program. In addition, ASK Consulting offers unpaid leave and paid sick leave as required by law.

ASK Consulting is an equal‑opportunity employer and does not discriminate against employees or applicants based on race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability, veteran status, or any other classification protected by federal, state, or local laws.