PROCESS ENGINEER I/II/III (PDE-004)

General Job Description/Team Overview: 

The Process Engineer will be a supporting member of the Process Development and Engineering team, to help in the design, implementation, and sustainability of manufacturing processes from feasibility through scale-up and to facilitate process tech transfer. The emphasis for this role focuses on ensuring robust systems using accepted GMP design controls, working within a regulated environment, and making data-driven decisions. The level will be determined based upon the candidate’s education, skills, and/or related experience.

Primary Duties and Responsibilities (include but are not limited to):

• Conduct lab and pilot-scale bioreactor experiments and downstream purifications. 

• Help design, develop and optimize upstream cell culture processes (Batch, Fed-Batch, Perfusion). 

• Help manage upstream and downstream process development activities. 

• Assist in the design, development, and implementation of a novel TFF system for downstream processing.  

• Provide technical support for technology transfer and implementation of manufacturing processes and controls. 

• Maintain accurate and complete lab records and other documentations (SOPs, MBRs, data reports), in preparation for the review, write-up, scientific reviews, and updates. 

• Assist with manufacturing operations as required. 

• Comply with all GenVivo safety requirements, cGMP, GenVivo SOPs, and manufacturing documentation.

 • Maintain appropriate interpersonal relationships with all members of management, company employees, service providers, technical support staff, and all others associated with, relating to, or doing business with the company 

• Perform other duties as assigned. 

Required Qualifications:

• Master’s Degree in Biological Engineering or relevant Science/Engineering discipline, or a Bachelor’s Degree in a relevant discipline with 2+ years of industry experience. 

• Strong knowledge in Cell Culture bioprocessing 

• Proficient in computer skills including Microsoft Office (Word, Excel, PowerPoint) and others as applicable. 

• Excellent organization skills with attention to detail and accurate record keeping.

• General knowledge of Federal and State regulatory requirements in a GxP environment. 

• High degree of discretion dealing with confidential information. 

• Ability and willingness to work flexible hours when needed.

• Demonstrated ability to work independently and in a team environment.

• Excellent written, verbal, and interpersonal communication skills. 

• Eligible to work in the U.S. 

Job Type: Full-time