AbbVie
Engineer, Validation Commissioning
North Chicago, IL, United States
Sponsorship not specifiedDetected 15 hours ago
NegotiationPLCMedical DevicesLeadershipCommunicationSCADA
About the role
- For more information about AbbVie, please visit us at www.abbvie.com.
- Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
- Level of responsibility and performance is commensurate with grade level.
Responsibilities
- Work with end-user and project engineer, automation engineers, and system owners to develop User Requirements Specifications and Functional / Design Specifications for new or modified equipment, facilities, and utilities.
- Support Factory Acceptance Testing and related system verification activities to confirm equipment and automation solutions meet defined requirements before site deployment.
- Identify risk controls, critical elements and traceability of equipment design based on FMEA or other risk assessment.
- Develop and execute commissioning, qualification, and validation test protocols for equipment, utilities, and automated or computer-controlled systems to ensure performance against specifications.
- Perform minor troubleshooting of issues encountered during commissioning including control logic, integration, instrumentation, recipe/parameter settings, and documentation of unresolved issues.
- May support aspects of projects at times such as: project leadership, developing operational procedures, support training of maintenance/technical staff/operators on new equipment, reviewing new or modified product documentation to ensure compatibility with qualified equipment and implementing changes in equipment parameters or recipes.
- Supports Execution of Risk Management including, periodic review and update per the Validation Master Plan, interface with best practices, ccRA.
- May perform FMEA authorization/facilitation.
- Ability to manage multiple projects (3+) simultaneously
- The role also contributes to optimizing automated systems, process controls, and related technical workflows that support reliable and compliant manufacturing operations
Requirements
- Experience with Computer System Validation (CSV) is required.
Nice to have
- 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.
- Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing preferred
Benefits
- AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.
- A technical background in health care, nutritional products, laboratory diagnostics, medical devices, pharmaceutical, or similar industries (preferred).
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
Company info
- Works with contract validation resources as part of a team in the timely completion of activities in his/her area of responsibility
- Works with junior or contract team members as part of a team
- We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio.
Equal opportunity
- Employer/Veterans/Disabled.
- US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
- US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
- https://www.abbvie.com/join-us/reasonable-accommodations.html
This listing is sourced directly from AbbVie's careers page and normalized into a canonical job model.