Job DescriptionSenior Validation Engineer / Decommissioning LeadLocation: North Chicago, IL - onsite
Contract: 15+ months duration,anticipated project completion February 2028
Schedule: Approximately 40 hours per week, subject to client approval
Position SummaryThis is a hands-on technical leadership role requiring experience with qualifications 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, 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.
RequirementsQualifications- 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.
Preferred Experience- 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.
