Senior Lead Engineer Process (BLS)

Exyte; Chandler (AZ); On-site; USD 150,000 - 190,000; Full time

Job summary

Exyte is seeking a Senior Lead Process Engineer to head a system design team responsible for high-purity gas and chemical production, biologics processing, and related utilities. The role requires leading engineering efforts from concept through construction with strict adherence to cGMP and regulatory standards.

The candidate will mentor junior staff, coordinate with regional experts, and drive standardization across projects to improve repeatability and efficiency in ATF/LSC programs.

Qualifications

• Bachelor’s degree in Chemical Engineering or related field.
• 8+ years of experience in biotech process engineering (mAbs).
• Experience in leading teams and workgroups on ATF or LSC projects.

Responsibilities

• Leads a team of engineers and/or designers to create and document designs that fulfill project scope and client standards with minimal supervision.
• Designs and optimizes biologics and mAbs related manufacturing processes.
• Ensures compliance with cGMP and global regulatory standards.
• Develops system designs from Concept Phase through Construction Documents.
• Responsible for quality control and approval of concepts, basis of design, PID diagrams, piping and equipment plans, cost and schedule for all Process Systems.
• Contributes to the Process Knowledge Center by documenting lessons learned and sharing information.

Skills

Team leadership

Process engineering

Biologics processes

cGMP compliance

Mentoring juniors

Project coordination

Education

Bachelor's degree in Chemical Engineering

Job description

Discover your exciting role

The Senior Lead Process Engineer is responsible for leading a system design team on projects. Systems can includeproduction 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 cleanand support utilities.

Explore your tasks and responsibilities

• Works with or leads a team of engineers and/or designers to create and document designs fulfilling theproject 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, processand instrumentation diagrams, piping and equipment plans, details, specifications, cost, and schedule for allProcess Systems
• Contributes to the Process Knowledge Center via documenting lessons learned, completing CIP assignmentsfrom 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 otherresponsibilities 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

Show your expertise

Minimum Required:

• Education: 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

Preferred:

• 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

Contact:

You want to be part of the Exyte team? For further questions and information, please do not hesitate to contact Tina Denny.

Please note that we only consider applications submitted through our application portal. Applications sent via email will not be considered due to data protection regulations.

Exyte US, Inc. is proud to be an Aff matted Action and Equal Employment Opportunity employer that is committed to celebrating diversity and supporting an inclusive workplace where associates excel based on personal merit,qualifications, experience, ability, and job performance. We prohibit discrimination and harassment of any kindbased on race, color, religion, age, sex (e.g., pregnancy, childbirth and related medical conditions, sexualorientation, gender identity or expression), national origin, disability status, genetic information, protected veteranstatus, or any other protected characteristic as outlined by federal, state, or local laws.