Senior Manager, Packaging, Aseptic
About The Position
AbbVie is recruiting a Senior Manager, Packaging, Aseptic to join the core startup leadership team for its new manufacturing campus in Durham, North Carolina. The campus will support production of medicines in immunology, oncology, and neuroscience and will include manufacturing facilities, laboratories, a warehouse, administrative offices, and employee wellness facilities. The role provides technical leadership for the SVP filling line and associated aseptic equipment, from design and integration through testing, startup, and process validation. The position establishes technical requirements, design criteria, operating ranges, critical parameters, and acceptance criteria to support safe, reliable, high-quality aseptic manufacturing. It leads technical coordination across equipment suppliers, architecture and engineering, automation, operations, quality, and other engineering disciplines, while ensuring interfaces and assumptions are addressed. The Senior Manager provides expertise in aseptic design, GMP operation, cleaning and decontamination, maintainability, and contamination control. The role leads technical reviews, resolves equipment and process issues, analyzes performance data, supports deviation investigations and corrective actions, and maintains disciplined documentation of requirements, assumptions, risks, decisions, and actions. It also guides engineers, facilitates technical working sessions, recommends risk mitigations, and communicates progress and impacts to project leaders and stakeholders. The position requires travel 50% of the time.
Requirements
- Bachelor’s degree in Engineering or a similar related discipline.
- Eight or more years of relevant industry experience.
- Experience in drug substance, drug product, biologics, and/or aseptic sterile fill finish is required.
- Ability to partner cross-functionally with successful teams in a GMP manufacturing environment.
- In-depth knowledge typically obtained through advanced education and experience.
Nice To Haves
- Prior experience in a startup facility.
Responsibilities
- Lead technical workstreams and contribute to program outcomes through actionable methods, analyses, cross-functional collaboration, and advice on complex technical decisions and risks.
- Define site-level processes and improvements, including operating ranges, critical parameters, and acceptance criteria for efficient, high-quality production.
- Lead process improvement and optimization workstreams; define technical approaches, coordinate production trials, and document results.
- Conduct process validation and manufacturing troubleshooting by analyzing performance data, investigating deviations, and drafting corrective actions and supporting documentation for review and approval.
- Establish technical standards for process documentation and change execution, ensuring methods, assumptions, and evidence are complete.
- Guide engineers through technical decisions by facilitating working sessions, documenting decision logic, and tracking actions to closure.
- Deliver technical outputs for complex projects and programs; validate methods, document results and assumptions, ensure adherence to standards and controls, and communicate progress, impacts, and mitigations.
- Serve as technical lead and subject-matter expert for the SVP filling line and associated equipment; establish requirements, design criteria, operating ranges, critical parameters, and acceptance criteria.
- Lead technical evaluation and integration of the filling-line equipment package with upstream and downstream processes, facility systems, utilities, automation, and supporting equipment.
- Coordinate technical decisions with the A/E, equipment suppliers, automation teams, operations, quality, and other engineering disciplines; identify and resolve interfaces and assumptions.
- Ensure filling-line design supports aseptic processing, GMP operation, cleaning and 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.
- Provide technical leadership through equipment testing and transition from design into execution and startup; support issue resolution and establish technical acceptance criteria, system performance expectations, and documentation.
- Own filling-line technical decisions and document 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.
Benefits
- Paid time off, including vacation, holidays, and sick time.
- Medical insurance.
- Dental insurance.
- Vision insurance.
- 401(k).
- Eligibility to participate in long-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
