Decommissioning Validation Lead — Pharma Equipment

Automated Systems, Inc. (ASI); North Chicago (IL); Vor Ort; USD 110.000 - 170.000; Vollzeit

Zusammenfassung

Automated Systems, Inc. (ASI) is seeking a Senior Validation Engineer to lead decommissioning activities for pharmaceutical equipment, utilities and lab systems at a North Chicago, IL site.

This hands-on role requires experience with qualification documentation, engineering judgment, and cross-functional collaboration to deliver reviews and final deliverables on schedule. The successful candidate will work with QA, Validation, Engineering, Operations and project leadership to establish

Qualifikationen

• 5+ years of pharma qualification, validation or decommissioning experience.
• Experience authoring and executing qualification and decommissioning documentation.
• Strong GMP documentation, change control, deviations and approvals.
• Ability to manage deliverables across Engineering, Operations, Validation and QA.
• Ability to read technical docs and develop clear rationale.
• Strong technical writing, meeting facilitation and follow-through.
• Enjoys independent work and accountable for completion.
• Engineering degree or equivalent technical discipline.

Aufgaben

• Plan and coordinate decommissioning activities, ownership, sequencing, reviews and closure.
• Assess equipment boundaries and control documentation pathways.
• Author and execute decommissioning protocols and ECM docs.
• Coordinate work across fermenters, tanks, sterilizers, process utilities and lab systems.
• Lead discussions with QA and stakeholders to clarify requirements and decisions.
• Document technical basis for recommendations and resolve disagreements.
• Identify schedule risks and present practical options to project lead.
• Coordinate junior resources and perform independent document reviews.
• Manage routing, comments, pre- and post-approval in Kneat/OneVault/OneTrack.
• Investigate execution issues and deviations with stakeholders.
• Lead coordination meetings and participate in validation review board meetings.
• Provide weekly reports on planned vs actual activities, risks and hours.

Kenntnisse

Technical writing

Project coordination

Cross-functional collaboration

Independent work

Quality Assurance

Ausbildung

Engineering degree

Tools

DeltaV

Provox

OSI PI

Kneat

OneVault

OneTrack

Jobbeschreibung

Automated Systems, Inc. (ASI) is seeking a Senior Validation Engineer to lead decommissioning activities for pharmaceutical equipment, utilities and lab systems at a North Chicago, IL site.

This hands-on role requires experience with qualification documentation, engineering judgment, and cross-functional collaboration to deliver reviews and final deliverables on schedule. The successful candidate will work with QA, Validation, Engineering, Operations and project leadership to establish