Senior Packaging & Aseptic Manufacturing Lead

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

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.