Process Engineer, MSAT

Principal Duties And Responsibilities

• Design, develop, execute and characterize process development studies.
• Design and develop unit operations of a scalable commercial manufacturing process.
• Implement and integrate automated systems into a complex manual process.
• Absorb and communicate study designs, data analysis and conclusions to project team members.
• Create technical, written content.
• Analyze and evaluate the impact of process variables on combination product characteristics.
• Communicate with MSAT group and project team members.
• Serve as an MSAT SME in cross-functional interactions with other departments.

Requirements

• Minimum of a bachelor’s degree (advanced degree desirable) in Chemical Engineering, Biomedical Engineering, Mechanical Engineering or related discipline.
• 4+ years of biopharma industry experience in drug or combination process development.
• Prior experience working within a cGMP manufacturing environment.
• Ability to apply fundamental scientific and engineering skills to evaluation of processes and development of practical solutions to technical challenges.
• Experience creating technical, written content.
• Demonstrated written and verbal communication skills.
• Demonstrated data analysis and problem-solving skills.
• High degree of initiative and self-motivation.
• Diligent team-player that is passionate about helping patients and effectively collaborates in a dynamic, cross-functional environment.
• Experience with generic lab equipment (Ex. pipettes, balances, pumps, microscopes) is preferred.
• Experience with automated or manual inspection systems is preferred.

Working Conditions

• Production Floor – gowning/cGMP requirements.
• Laboratory/Clean Room – bending/lifting requirements.