Senior Validation Engineer / Decommissioning Lead

Senior Validation Engineer / Decommissioning Lead North Chicago, United States | Posted on 10/27/2026 Industry Pharma/Biotech/Clinical Research Work Experience 5+ years City North Chicago Country United States Job Description SeniorValidation Engineer / Decommissioning Lead Location: North Chicago, IL - onsite Contract: 15+ months duration, anticipatedproject completion February 2028 Schedule: Approximately 40 hours per week, subject to client approval PositionSummary AutomatedSystems, Inc. (ASI) is seeking a Senior Validation Engineer to leaddecommissioning activities for pharmaceutical fermentation manufacturingequipment, utilities, laboratory equipment, and associated automation systemsat our global pharmaceutical manufacturing client’s facility located in NorthChicago, IL. Thisis a hands-on technical leadership role requiring experience with qualificationsand decommissioning documentation, sound engineering judgment, and the abilityto drive work through review and approval. In this role, the successfulcandidate will work directly with Quality Assurance, Validation, Engineering,Operations, and the project leader to establish clear requirements, resolvequestions, and complete deliverables on schedule. Weare looking for someone who can explain technical issues clearly to reviewerswith different backgrounds, make practical recommendations supported bydocumented rationale, and maintain productive working relationships whenpriorities or interpretations differ. Responsibilities Plan and coordinate decommissioning activities,including document ownership, execution sequencing, review cycles, andfinal closure. Assess equipment, system boundaries, and associatedcontrols to determine the appropriate documentation and change-controlpathway. Author and execute decommissioning protocols andEngineering Change Management documentation. Coordinate work involving fermenter, seed and holdtanks, sterilizers, process utilities, laboratory equipment, andassociated control systems. Lead discussions with QA and technical stakeholders toclarify requirements, resolve comments, and secure timely decisions. Distinguish procedural requirements from preferences,document the technical basis for recommendations, and resolvedisagreements professionally. Support the project lead by identifying schedule risksearly, presenting practical options, and escalating unresolved decisionswith clear recommendations. Coordinate the assignments of junior resources andperform independent technical reviews of documents prepared by others. Manage document routing, comment resolution,pre-approval, and post-approval in applicable AbbVie systems, such asKneat, OneVault, and OneTrack. Investigate and resolve execution issues and deviationswith the appropriate stakeholders. Lead coordination meetings and participate in ProjectValidation Review Board meetings as needed. Provide weekly reports covering planned versus actualactivities, risks, roadblocks, and hours. Requirements Qualifications 5+ years of relevant pharmaceutical or biotechnologyqualification, validation, or decommissioning experience. Experience authoring and executing qualification anddecommissioning documentation for manufacturing equipment, utilities, orlaboratory systems. Strong understanding of GMP documentation, changecontrol, deviations, and document approval processes. Demonstrated ability to manage deliverables acrossEngineering, Operations, Validation, and QA. Ability to read technical documentation, understandequipment and system interfaces, and develop clear, defensible technicalrationale. Strong technical writing, meeting facilitation, andfollow-through. Comfortable working independently, addressingconflicting feedback, and maintaining accountability for completion. Degree in engineering or a related technicaldiscipline. PreferredExperience Fermentation, API manufacturing, or pharmaceuticalfacility shutdown projects. Familiarity with DeltaV, Provox, OSI PI, or relatedmanufacturing automation and data systems. Relevant experience and familiarity with Kneat,OneVault, or OneTrack. #J-18808-Ljbffr Automated Systems, Inc.