Process Engineer

Role Overview

We are a world-leading cell and gene therapy contract development and manufacturing organization. Our collaborative team works to create cutting-edge therapies that change people's lives.

The Process Engineer will be responsible for technology transfers, troubleshooting, and process improvements in our manufacturing facility.

Key Responsibilities:

• Partner with colleagues in Manufacturing, Supply Chain, Facilities, Metrology/Validation, Quality Control, and Quality Assurance as well as external clients and suppliers.
• Draft and design GMP Batch Records and SOPs to support partner programs.
• SUPPORT GMP production with process or equipment troubleshooting, deviation management, corrections, and CAPA as needed.
• Lead the New Product Introduction for products entering the RoslinCT facility.
• Execute feasibility testing of new or alternative technologies.

Requirements:

• Bachelor's degree in Biological, Biomedical or Chemical Engineering (or similar) with at least 3 years relevant experience within the Cell Therapy industry.
• Hands-on experience with aseptic manufacturing processes, cell culture, and cell therapy instrumentation.
• Experience with cell therapy equipment support and troubleshooting.
• Proficiency with Quality Systems including but not limited to Deviations, CAPAs, and Change Controls.

Preferred Qualifications:

• Advanced degree or additional certifications in science, engineering, or cGMP operations.
• Experience in hands-on training curriculum development for cell therapy manufacturing personnel.
• Experience supporting both clinical and commercial cell therapy programs.

Culture & Values

All RoslinCT employees embrace the principles of our culture and values and are deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways.