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

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

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 systemsat our global pharmaceutical manufacturing client’s facility located in North Chicago, IL.

Thisis a hands-on technical leadership role requiring experience with qualification sand decommissioning documentation, sound engineering judgment, and the abilityto 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.

Weare 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.

• Plan and coordinate decommissioning activities,including document ownership, execution sequencing, review cycles, andfinal 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 holdtanks, sterilizers, process utilities, laboratory equipment, and associated 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 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 Abb Vie systems, such as Kneat, One Vault, and One Track.
• 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.

• 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, changecontrol, 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, andfollow-through.
• Comfortable working independently, addressing conflicting feedback, and maintaining accountability for completion.
• Degree in engineering or a related technical discipline.

• 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,One Vault, or One Track.