Process Support Engineer

About the Role

BioSpace is seeking a Process Support Engineer to join our Integrated Manufacturing Support team. This non-lab based role focuses on problem solving and performing scientific and technical investigations. They will serve as a subject matter expert (SME) to support biopharmaceutical production activities across our manufacturing site.

Location

• Rensselaer, New York, United States

Work Schedule

• Monday-Friday, 8am-4:30pm

Key Responsibilities

• Lead, author, and/or review scientific root cause investigations and develop corrective action plans to resolve complex deviations related to process control and product quality.
• Perform data analysis and apply statistical process control tools for trending and analyzing process-related data to drive consistency and improvements.
• Serve as a Subject Matter Expert (SME) by utilizing a science-based approach and through analysis of historical data to support production, purification, and formulation activities.
• Present process data and investigational findings at group and department meetings.
• Monitor production processes to proactively acquire vital data in support of preventing issues and tracking efficiency of changes.
• Interact with Manufacturing, Quality Assurance, Quality Control, Manufacturing Sciences & Technology, and Process Sciences laboratory teams to drive root cause investigations and implement process improvements.

Requirements & Tech Stack

• Knowledge of cell culture, purification/chromatography operations, analytical methods (i.e. UPLC, ELISA, PCR), and/or material sciences, and statistical analyses.

Qualifications

• BS in Engineering; chemical engineering or biological engineering preferred.

• Level will be determined based on experience.

• Associate Process Support Engineer: 0-2+ years of experience

• Process Support Engineer: 2+ years of experience

• Sr. Process Support Engineer: 5+ years of experience