Manager, Process Engineering

ElevateBio is a technology-driven cell and gene therapy company looking to hire a Manager Process Engineering at its BaseCamp Pittsburgh facility. The role involves introducing new process equipment, working with production personnel, and ensuring the validated status of process equipment. The successful candidate will manage the equipment lifecycle, troubleshoot activities, and provide technical support for manufacturing suites.

Requirements

• 6+ years of experience in GMP biotech engineering or an FDA regulated manufacturing facility.
• 2+ years of management leadership/supervisory experience in hiring, building, training, and leading high-performance teams.
• BS degree in a related Engineering field in Biotech/Pharmaceuticals.
• Experience in cGMP facility/equipment start-up, processing, and qualification.
• Required experience with good documentation practices and cGMP standards.
• Experience in cGMP processes such Cell Therapy, Gene Therapy, and/or mRNA production.
• Experience in Cell Cultures/Viral Vectors is a plus.
• Strong technical writing skills with experience writing Requirement Specifications (Design, Functional, User), FMEAs, FAT/SAT/Commissioning Protocols, SOPs and Work Instructions.
• Mastery of skills required to read, understand, and adhere to the SOPs and policies of a GMP environment.
• Strong interpersonal and verbal communication.

Benefits

• Retirement Plan
• 401k Matching
• Generous Paid Time Off