Lead Process Engineer

Exyte GmbH • Raleigh, NC

2d

About The Position

The Lead Process Engineer is responsible for leading a system design team on projects. Systems can include production and distribution of high purity gases and chemicals, upstream and downstream biologics processing, small molecule synthesis, fill/finish, and specialty chemicals, and high purity water, waste treatment, and clean and support utilities.

Requirements

• Bachelor’s degree in Chemical Engineering or related field required
• 8+ years of experience in biotech process engineering (mAbs - monoclonal Antibodies)
• Experience in leading teams and workgroups, small to medium, on ATF or LSC projects

Nice To Haves

• Professional Engineer (PE) License preferred
• Nation Council of Examiners for Engineering and Surveying (NCEES) Record preferred
• Prior experience with 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

• Works with or leads a team of engineers and/or designers to create and document designs fulfilling the project design scope consistent with industry-accepted practice as well as client-preferred standards, with minimal supervision
• Design and optimize biologics and mAbs - related manufacturing processes.
• Ensure compliance with cGMP and global regulatory standards.
• Develops system design from Concept Phase through Construction Documents
• Responsible for 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 all Process Systems
• Contributes to the Process Knowledge Center via documenting lessons learned, completing CIP assignments from regional system expert, and use of information developed by others in process discipline
• Supports the Design Manager and Construction Manager with Fee Development Guide, change orders, quality assurance, scheduling, staffing, progress report outs, interdisciplinary coordination, and other responsibilities as agreed to by the project lead and/or Discipline Director
• Works as a Task Force Lead coordinating with Regional System Experts and project leads to identify and develop system specific standard tools (drawings, specifications, checklists, calculators) for lean project execution, promoting project to project repeatability and consistency across ATF/LSC segments
• Mentors and trains junior staff
• Other duties as assigned

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees