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Exyte · 1 day ago

Lead Process Engineer

Raleigh, NC

Full-time

Onsite

Lead/Staff

8+ years exp

Exyte is a company that specializes in high purity gas and chemical systems, and they are seeking a Lead Process Engineer to oversee system design projects. The role involves leading a team, ensuring compliance with regulatory standards, and optimizing manufacturing processes in the biotech field.

Civil Engineering

No H1B

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

Qualification

Chemical EngineeringBiotech Process EngineeringTeam LeadershipCGMP ComplianceQuality ControlBiopharma ExperienceContinuous ImprovementConsulting EngineeringMentoring