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Role Summary
Automation/Controls Engineer (onsite role in North Chicago).
Responsibilities
Support a Safe working environment by aligning with all pertinent environmental health, safety & maintenance program practices, rules, and regulations.
Understanding of cGMP processing with change control, nonconformance, corrective & preventative actions, and Commissioning & Qualification activities.
Experience with the following product platforms (preferred): Rockwell PLC Platform; Emerson DeltaV; ABB DCS; PI Data Historian System.
Day-to-day Operational Support: 24 x 7 Onsite/On Call (as needed); Troubleshooting support to Utilities operations.
Be a knowledgeable controls SME for all Utilities equipment operations by: Troubleshooting activities in partnership with the Operations, Engineering and Maintenance teams to enhance utilities uptime through the highest reliability of Automation systems.
Continuous improvement in partnership with Operations, Engineering, Maintenance, Manufacturing, Process engineering and OpEx to drive operational efficiencies.
Collaborate within the AbbVie network to learn, implement and share Continuous improvement opportunities within the AbbVie Global Operations network.
Apply automation engineering principles in the design, specification, construction, startup, commissioning and qualification of process equipment and systems for capital projects of significant scope and complexity. Demonstrated understanding of project life cycles is preferred.
Develop and maintain Engineering Specifications, documents, drawings, and Standard Operational Procedures (SOP) including Administrative SOPs and Job Aids; provide AbbVie User requirements to OEMs/System Integrators for PLC, HMI, SCADA, and DCS applications.
Converse with industry standards on quality and regulatory compliance requirements such as 21 CFR Part 11 (Data Integrity, User Security, System Disaster Recovery, Data Backup & Restore).
Communicate in the simplest business language at various partner forums in the workplace.
Qualifications
Bachelor’s degree in Electrical Engineering, Mechanical Engineering, Chemical Engineering, Computer Science, or related field is required.
Minimum 2-4 years’ experience developing and maintaining automation/controls software and equipment and PLC systems in a manufacturing environment; AI and machine learning experience, including new technology development for new product introductions, is a plus.
Direct experience with system development and validation, including DS/FS/URS development and risk-based validation strategies, and validation protocol development and execution.
Demonstrated knowledge of 21 CFR Part 11 requirements for automated systems in the pharmaceutical or medical device industries.
Demonstrated problem solving skills and innovative thinking to develop and implement untested solutions; possesses working technical knowledge and application of concepts, practices, and procedures.
Ability to work on problems of moderate scope with sound judgment within defined procedures; strong collaboration across diverse groups.
Interpersonal skills to negotiate and reconcile differences; effective communication in writing and presentations.
Technical background in health care, medical devices, pharmaceutical, biologics, or similar industries (preferred).
Skills
PLC/SCADA/HMI/DCS programming and integration
Process automation and control systems
Regulatory compliance and data integrity (21 CFR Part 11)
Cross-functional collaboration
Engineering documentation and SOP development
Education
Bachelor’s degree as listed in Qualifications