Senior Lead Engineer Process (BLS)

Exyte GmbH•Chandler, AZ

19d

About The Position

The Senior Lead Process Engineer leads a system design team on projects involving systems such as high-purity gas and chemical production and distribution, biologics processing, small-molecule synthesis, fill/finish, specialty chemicals, high-purity water, waste treatment, and clean and support utilities. The role develops and optimizes biologics and mAbs-related manufacturing processes and leads system design from the Concept Phase through Construction Documents, with minimal supervision. Designs must meet project scope and align with industry-accepted practices and client-preferred standards, while complying with cGMP and global regulatory standards. The engineer is responsible for quality control and approval of process design deliverables, including concepts, basis of design, process flow diagrams, process and instrumentation diagrams, piping and equipment plans, details, specifications, cost, and schedule. The position also contributes to process knowledge and continuous improvement, supports project management and construction management activities, develops standardized tools for repeatable project execution, and mentors and trains junior staff.

Requirements

Bachelor’s degree in Chemical Engineering or a related field.
At least 8 years of experience in biotech process engineering, specifically mAbs (monoclonal antibodies).
Experience leading small- to medium-sized teams and workgroups on ATF or LSC projects.

Nice To Haves

Professional Engineer (PE) license.
National Council of Examiners for Engineering and Surveying (NCEES) Record.
Prior experience in Biopharma Life Sciences.
Prior experience in consulting engineering.
Experience working within a team environment.
Experience in the quality control review process.
Experience contributing to continuous improvement processes.

Responsibilities

Work with or lead a team of engineers and/or designers to create and document designs that fulfill project scope and align with industry-accepted practices and client-preferred standards, with minimal supervision.
Design and optimize biologics and mAbs-related manufacturing processes.
Ensure compliance with cGMP and global regulatory standards.
Develop system designs from the Concept Phase through Construction Documents.
Provide quality control and approval of concepts, basis of design, process flow diagrams, process and instrumentation diagrams, piping and equipment plans, details, specifications, cost, and schedule for Process Systems.
Contribute to the Process Knowledge Center by documenting lessons learned, completing CIP assignments from the regional system expert, and using information developed by others in the process discipline.
Support the Design Manager and Construction Manager with fee development, change orders, quality assurance, scheduling, staffing, progress reporting, interdisciplinary coordination, and other agreed-upon responsibilities.
Work as a Task Force Lead with Regional System Experts and project leads to identify and develop system-specific standard tools, including drawings, specifications, checklists, and calculators, for lean project execution and repeatability across ATF/LSC segments.
Mentor and train junior staff.
Perform other duties as assigned.