Senior Validation Engineer / Decommissioning Lead

Senior Validation Engineer / Decommissioning Lead

Location: North Chicago, IL - onsite

Contract: 15+ months duration, anticipated project completion February 2028

Schedule: Approximately 40 hours per week, subject to client approval

Position Summary

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

This is a hands-on technical leadership role requiring experience with qualification and decommissioning documentation, sound engineering judgment, and the ability to drive work through review and approval. In this role, the successful candidate will work directly with Quality Assurance, Validation, Engineering, Operations, and the project leader to establish clear requirements, resolve questions, and complete deliverables on schedule.

We are looking for someone who can explain technical issues clearly to reviewers with different backgrounds, make practical recommendations supported by documented rationale, and maintain productive working relationships when priorities or interpretations differ.

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 fermenters, 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.

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.

Preferred Experience

• Fermentation, API manufacturing, or pharmaceutical facility shutdown projects.
• Familiarity with DeltaV, Provox, OSI PI, or related manufacturing automation and data systems.
• Relevant experience and familiarity with Kneat, OneVault, or OneTrack.