Senior Manager, Packaging, Aseptic

Job Description

New to North Carolina. Known for pursuing breakthroughs in medicine.

Ready to join our team?

At AbbVie, we bring together talented people and innovative science to develop medicines that help patients. Now, we’re bringing that commitment to Durham, North Carolina, with a new manufacturing campus that will expand our ability to produce medicines and create opportunities in the Research Triangle.

The campus will integrate advanced manufacturing, laboratory technologies and AI to support the production of immunology, oncology and neuroscience medicines. The first phase will include manufacturing facilities, next-generation laboratories, a warehouse, administrative offices and employee wellness facilities.

To learn more about this investment, please visit https://www.abbvie.com/abbvie-north-carolina-manufacturing.html

We are now recruiting our Sr. Manager, Packaging, Aseptic as part of the core start up leadership team.

KEY RESPONSIBILITIES
The job leads technical workstreams and contributes to program outcomes by developing actionable methods and analyses, collaborating with cross‑functional partners to integrate technical solutions throughout the lifecycle, and advising on complex technical decisions and risks.
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.

1. 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.

2. 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.

3. 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.

4. Testing, Qualification, Startup & Process Validation
Provide technical leadership through equipment testing and the transition from design into execution and startup. Support resolution of equipment and process issues and ensure technical acceptance criteria, system performance expectations, and supporting documentation are clearly established. The generic role explicitly includes process validation, troubleshooting, performance-data analysis, investigation of deviations, and documentation of corrective actions.

5. Technical Governance, Risk Management & Decision Making
Own key filling-line technical decisions and maintain disciplined documentation of requirements, assumptions, risks, decisions, and actions through closure. Facilitate technical working sessions, evaluate complex issues, recommend mitigation strategies, and communicate impacts to project leadership and cross-functional stakeholders. This closely reflects the T7 expectations to guide engineers through technical decisions, document decision logic, track actions, and advise on complex technical risks.

Qualifications

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