Engineer, Validation Commissioning

AbbVie•North Chicago, IL

21h•$65,500 - $125,500

About The Position

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.

Requirements

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
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.
2+ years of overall experience in Manufacturing, Quality or Engineering including 2 major validation subjects (e.g. Computer, Equipment, Cleaning, Process, etc.) preferred
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).
Strong interpersonal, communication, and negotiation skills with demonstrated ability to work within a team environment.
Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing preferred
Works with junior or contract team members as part of a team
Ability to manage multiple projects (3+) simultaneously

Responsibilities

Work with end users, project engineers, and system owners to develop User Requirements Specifications and Functional/Design Specifications for new or modified facilities, utilities, and HVAC systems.
Support Factory Acceptance Testing and related verification activities to confirm facility and utility systems meet defined requirements prior to site deployment.
Identify risk controls, critical elements, and traceability of design requirements based on FMEA or other risk assessment approaches for qualified facilities and utility systems.
Develop and execute commissioning, qualification, and validation protocols for facilities, utilities, HVAC systems, and environmental/viable monitoring systems to ensure performance against specifications and intended use.
Perform minor troubleshooting of issues encountered during commissioning, including control logic, integration, instrumentation, documentation, and qualification deliverables.
May support project activities such as project leadership, development of operational procedures, training of maintenance/technical staff/operators on new equipment and utilities, reviewing new or modified documentation for compatibility with qualified systems, and implementing changes to equipment parameters or facility-related settings.
Support execution of risk management activities, including periodic review and update per the Validation Master Plan, interface with best practices and ccRA, and understanding of risk management principles, trace controls, change impact assessments, and rating scales. May perform FMEA authorization/facilitation as needed.
May serve as a QRM facilitator commensurate with responsibility.
Work with contract validation resources as part of a team to support timely completion of qualification activities within assigned area of responsibility.