Senior Manager, Packaging, Aseptic at AbbVie · LumiJobs

Responsibilities

Designs site-level processes and improvements by defining operating ranges, critical parameters, and acceptance criteria that support efficient, high-quality production.
Leads process improvement and optimization workstreams, defining the technical approach, coordinating trial execution with production, and documenting results.
Conducts process validation and troubleshooting for manufacturing processes manufacturing processes by analyzing performance data, investigating deviations, and drafting corrective actions and supporting documentation for review and approval
Establishes technical standards for process documentation and change execution, ensuring methods, assumptions, and evidence are complete.
Guides engineers through technical decisions by running working sessions, documenting decision logic, and tracking actions to closure.
Delivers high‐quality technical outputs for complex projects and programs; defines and validates methods, documents results and key assumptions, ensures adherence to applicable standards and controls, and communicates technical progress, impacts and recommended mitigations to project leads and stakeholders.
Filling Line & Aseptic Equipment Technical Leadership
Serve as the technical lead and SME for the SVP filling line, providing engineering leadership for the filling process and associated equipment. Establish technical requirements, design criteria, operating ranges, critical parameters, and acceptance criteria to support safe, reliable, and high-quality aseptic manufacturing. This aligns directly with the generic profile's accountability for defining operating ranges, critical parameters, and acceptance criteria.
Equipment Design, Vendor & System Integration
Lead technical evaluation and integration of the filling-line equipment package with upstream/downstream processes, facility systems, utilities, automation, and supporting equipment. Drive technical decisions with the A/E, equipment suppliers, automation teams, operations, quality, and other engineering disciplines, ensuring interfaces and assumptions are identified and resolved.
Aseptic Design, GMP & Contamination-Control Readiness
Provide filling-line expertise to ensure the design supports aseptic processing, GMP operation, cleaning/decontamination, material and personnel interfaces, maintainability, and contamination-control objectives. Lead technical reviews and challenge design decisions that could affect product quality, equipment performance, or reliable operation.

Senior Manager, Packaging, Aseptic

Responsibilities

Benefits

Company

AbbVie

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