Senior Manager, Packaging, Aseptic

AbbVie; Durham (NC); On-site; USD 140,000 - 200,000; Full time

Job summary

AbbVie in Durham, NC seeks a Sr. Manager, Packaging, Aseptic to lead filling-line technical workstreams and establish robust design and validation processes. You will define operating ranges, parameters, and acceptance criteria to ensure high-quality aseptic manufacturing.

The role collaborates across engineering, operations, and quality teams. The ideal candidate has an engineering degree with 8+ years in GMP manufacturing and aseptic fill-finish experience, preferably in a startup facility.

Qualifications

• Bachelors degree in Engineering or similar discipline required.
• 8+ years of relevant industry experience.
• Experience in drug substance, drug product, biologics and/or aseptic sterile fill finish is required.

Responsibilities

• Filling Line & Aseptic Equipment Technical Leadership: serve as technical lead and SME for the SVP filling line; establish requirements and acceptance criteria.
• Equipment Design, Vendor & System Integration: lead evaluation and integration of filling-line equipment with upstream/downstream processes and facility systems.
• Aseptic Design, GMP & Contamination-Control Readiness: ensure aseptic processing design, GMP operation, cleaning and contamination controls.
• Testing, Qualification, Startup & Process Validation: lead testing, startup, validation and documentation; resolve issues and capture actions.
• Technical Governance, Risk Management & Decision Making: own key decisions; document requirements, risks, and actions; communicate to stakeholders.

Skills

GMP manufacturing experience

Cross-functional collaboration

Startup environment

Process validation

Education

Bachelor's degree in Engineering

Tools

GMP manufacturing equipment

Job description

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Company Description
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

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.

• 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.
• 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.
• 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

• You will have in-depth knowledge typically obtained through advanced education and experience; with a Bachelors degree in Engineering or similiar related discipline and 8 + years relevant industry experience.
• Experience in drug substance, drug product, biologics and/or aseptic sterile fill finish is required
• You will have demonstrated your ability to partner cross functionally with successful teams in a GMP manufacturing environment and prior experience in a start up facility is preferred

Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html