Process Engineer – Cell & Gene

Blackfield Associates are workign with a new client who are manufacturing cell & gene therapy products for their client in Northern New Jersey. They are looking for multiple Process Engineers to join them on site.

This role will involve working closely with production personnel to onboard new process equipment, executing commissioning and qualification protocols, and ensuring the validated status of process equipment. The majority of process work will involve liquid formulations manufactured under single-use production concept, in a cleanroom environment. The successful candidate will work in compliance with cGMP and company standard operating procedures and policies.

Responsibilities will include analyzing and developing engineering solutions for manufacturing equipment, working collaboratively in a multi-functional team environment, troubleshooting and repairing bioprocess equipment, implementing equipment, facility and automation change control, leading engineering projects from start to finish, and working in cleanrooms and mechanical rooms on utility systems. The Process Engineer will be a company SME on bioprocess equipment across all operating departments and will work closely with manufacturing and laboratory personnel to troubleshoot and repair equipment, instrumentation and control issues.

The ideal candidate will have a Bachelor’s degree in Engineering, Chemical, Bioengineering or Mechanical Engineering, 2-5 years related work experience in GMP/Bio-Pharma maintenance/engineering, and knowledge of current Good Manufacturing Practices (cGMPs) for Phase I/II bulk and finished biologics. They will also possess strong technical writing and organizational skills, the ability to work to targets and deadlines, and a customer-focused, team player mindset. Supervisory experience is not required for this role.

STR Limited is acting as an Employment Agency in relation to this vacancy.