Associate Process Engineer/Scientist (Biologics Manufacturing)

Location: New Brunswick, NJ, United States

Company

hirify.global is a global staffing and IT consulting company supporting client staffing needs.

What you will do

• Conduct product and process characterization studies for sterile parenteral and biologics drug products.
• Design and execute experiments supporting product robustness, new technology implementation, process optimization, and manufacturing investigations.
• Collaborate with R&D development assets and manufacturing sites on post-market process changes and lifecycle management activities.
• Provide technical expertise on products and processes to internal and external teams involved in development, technology transfer, validation, specifications, and launch.
• Support global manufacturing sites in resolving significant quality events and managing complex change controls.

Requirements

• Bachelor’s degree in chemistry, pharmaceutical sciences, pharmacy, biology, chemical engineering, or a related science or engineering 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, especially 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, along with the ability to write and review complex study plans and scientific reports.
• Familiarity with sterile product processing equipment, manufacturing facilities, aseptic processing, sterilization, isolator processing, lyophilization, and pre-filled syringe operations.

Nice to have

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

Culture & Benefits

• Contract engagement lasting 6+ months with potential for extension.
• Confidential handling of candidate information in accordance with EEO guidelines.