Exyte
From Exyte's careers page
Status: listed on the employer's own careers page when we last checked (daily). Confirm on their site before applying.
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The Senior 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.
Explore your tasks and 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
Show your expertise
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
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 in the quality control review process
You want to be part of the Exyte team? We look forward to receiving your application!
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 Affirmative 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 kind based on race, color, religion, age, sex (e.g., pregnancy, childbirth and related medical conditions, sexual orientation, gender identity or expression), national origin, disability status, genetic information, protected veteran status, or any other protected characteristic as outlined by federal, state, or local laws.
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