Senior Validation Engineer & Decommissioning Lead

Automated Systems, Inc.; North Chicago (IL); On-site; USD 120,000 - 170,000; Full time

Job summary

Automated Systems, Inc. in North Chicago, IL is seeking a Senior Validation Engineer to lead decommissioning activities for pharmaceutical fermentation equipment, utilities, laboratory equipment, and associated automation systems at our global pharmaceutical client’s site in North Chicago.

This is a hands-on technical leadership role requiring qualifications, decommissioning documentation, sound engineering judgment, and the ability to drive deliverables on schedule.

Qualifications

• 5+ years of relevant pharmaceutical or biotechnology qualification, validation, or decommissioning experience.
• Experience authoring and executing qualification and decommissioning documentation for manufacturing equipment, utilities, or laboratory systems.
• Strong understanding of GMP documentation, change control, deviations, and document approval processes.
• Demonstrated ability to manage deliverables across Engineering, Operations, Validation, and QA.
• Ability to read technical documentation, understand equipment and system interfaces, and develop clear, defensible technical rationale.
• Strong technical writing, meeting facilitation, and follow-through.
• Comfortable working independently, addressing conflicting feedback, and maintaining accountability for completion.
• Degree in engineering or a related technical discipline.

Responsibilities

• Plan and coordinate decommissioning activities, including document ownership, execution sequencing, review cycles, and final closure.
• Assess equipment, system boundaries, and associated controls to determine the appropriate documentation and change-control pathway.
• Author and execute decommissioning protocols and Engineering Change Management documentation.
• Coordinate work involving fermenter, seed and hold tanks, sterilizers, process utilities, laboratory equipment, and associated control systems.
• Lead discussions with QA and technical stakeholders to clarify requirements, resolve comments, and secure timely decisions.
• Distinguish procedural requirements from preferences, document the technical basis for recommendations, and resolve disagreements professionally.
• Support the project lead by identifying schedule risks early, presenting practical options, and escalating unresolved decisions with clear recommendations.
• Coordinate the assignments of junior resources and perform independent technical reviews of documents prepared by others.
• Manage document routing, comment resolution, pre-approval, and post-approval in applicable AbbVie systems, such as Kneat, OneVault, and OneTrack.
• Investigate and resolve execution issues and deviations with the appropriate stakeholders.
• Lead coordination meetings and participate in Project Validation Review Board meetings as needed.
• Provide weekly reports covering planned versus actual activities, risks, roadblocks, and hours.

Skills

GMP documentation

Change control

Technical writing

Project coordination

Education

Engineering degree

Tools

Kneat

OneVault

OneTrack

DeltaV

Provox

OSI PI

Job description

Automated Systems, Inc. in North Chicago, IL is seeking a Senior Validation Engineer to lead decommissioning activities for pharmaceutical fermentation equipment, utilities, laboratory equipment, and associated automation systems at our global pharmaceutical client’s site in North Chicago.

This is a hands-on technical leadership role requiring qualifications, decommissioning documentation, sound engineering judgment, and the ability to drive deliverables on schedule.