Process Engineer (Biologics Manufacturing)

Location: New Brunswick, New Jersey, United States

Company

Pharmaceutical organization focused on biologics manufacturing science and technology.

What you will do

• Execute post-market process change activities and experiments in partnership with R&D development assets.
• Characterize, optimize, and troubleshoot sterile liquid biologics and parenteral dosage-form processes.
• Design and execute experiments supporting product robustness, new technology implementation, and manufacturing investigations.
• Provide technical expertise on products and processes to internal and external teams and committees.
• Support development, technology transfer, manufacturing, specifications, process validation, and product launch activities.
• Assist global manufacturing sites with significant quality events and complex change controls.

Requirements

• Bachelor’s degree in chemistry, pharmaceutical sciences, pharmacy, biology, chemical engineering, or a related discipline.
• 3–5 years of experience in pharmaceutical or biotechnology product and process development and commercialization in a global environment.
• Hands-on laboratory experience with sterile and liquid products, biologics, formulation development, analytical methods, commercial manufacturing, and unit operations.
• Knowledge of Quality by Design, Design of Experiments, multivariate analysis, Process Analytical Technology, critical process and material attributes, and critical quality attributes.
• Experience with Statistical Process Control and tools such as JMP, Minitab, or SAS, plus the ability to write and review complex study plans and scientific reports.
• Understanding of aseptic processing, sterilization, isolator processing, lyophilization, pre-filled syringe operations, sterile processing equipment, manufacturing facilities, and project management systems.

Nice to have

• Master’s or advanced degree.
• Six Sigma Green Belt or Black Belt certification.

Culture & Benefits

• Collaboration with R&D teams and manufacturing sites.
• Participation in internal and external technical teams and committees.
• Exposure to global biologics manufacturing operations and product commercialization.