Engineer, Validation Commissioning
North Chicago, IL, United States On-site
$65,500–$125,500 a yearJobFig found this opening at its original source and checks that it remains available.
About the role
An engineering professional that works with project owners, automation engineers, subject designers/engineers and other project team members to plan, and complete tasks associated with commissioning, qualification and validation of new and modified automated systems equipment, facilities, utilities, product, processes etc.in line with project, operations and quality objectives. Level of responsibility and performance is commensurate with grade level. The primary objective is to design and execute robust evaluation, testing, and documentation strategies that support risk management, commissioning, and validation in alignment with product, regulatory, and quality requirements. The role also contributes to optimizing automated systems, process controls, and related technical workflows that support reliable and compliant manufacturing operations
What you'll bring
- Experience in the development of commissioning, qualification, validation or risk management deliverables including specifications and testing protocols that can stand up to regulatory scrutiny.
- Experience with Computer System Validation (CSV) is required.
- Strong interpersonal, communication, and negotiation skills with demonstrated ability to work within a team environment.
- Works with junior or contract team members as part of a team
- Ability to manage multiple projects (3+) simultaneously
- Experience working with automation systems, controls, PLC/SCADA, instrumentation, or computer-based process controls strongly preferred.
- A technical background in health care, nutritional products, laboratory diagnostics, medical devices, pharmaceutical, or similar industries (preferred).
- Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing preferred
- Bachelor’s Degree in Engineering, science, or closely related discipline is desired, or equivalent technical experience plus demonstrated competence
- with a desired 1+ years of significant engineering and/or operational experience
- 2+ years of overall experience in Manufacturing, Quality or Engineering including 2 major validation subjects (e.g. Computer, Equipment, Cleaning, Process, etc.) preferred