Senior Process Engineer, Oral Solid Dosage Scale-Up

AbbVie; North Chicago (IL); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

401(k) matching

Medical/dental/vision insurance

Paid time off

Long-term incentive programs

Job summary

AbbVie seeks a senior process engineer to lead late-stage development, scale-up, validation, and commercialization of oral solid dosage products. You will apply engineering principles to develop robust processes, establish control strategies, facilitate technology transfers, and support regulatory submissions.

You will serve as a technical leader within cross-functional teams to ensure successful product commercialization and lifecycle management.

Qualifications

• Thorough understanding of pharmaceutical process engineering principles.
• Experience in oral solid dosage form development and commercialization.
• Experience scaling manufacturing from lab/pilot to commercial.
• Experience leading technology transfers across sites.
• Knowledge of DoE, QbD, and PPQ concepts.
• Effective writer and communicator of regulatory documentation, including CTD submissions.

Responsibilities

• Lead scale-up of oral solid dosage processes from pilot to commercial manufacturing.
• Develop and execute technology transfer strategies for internal and external sites.
• Apply design of experiments and models to support process development and scale-up.
• Establish node points for control strategies and critical process parameters.
• Lead characterization, PPQ, and validation activities for product commercialization.
• Draft and review CTD Module 3.2.P.2.3 content for regulatory submissions.
• Collaborate with Manufacturing, Quality, Regulatory Affairs, and Technical Operations to meet project goals.
• Adhere to code of conduct, safety, material handling, and GxP compliance.

Skills

Pharma process engineering

Design of Experiments

DoE & statistics

Cross-functional collaboration

Regulatory documentation

Education

Bachelor's in a relevant field

Master's degree

PhD

Job description

AbbVie seeks a senior process engineer to lead late-stage development, scale-up, validation, and commercialization of oral solid dosage products. You will apply engineering principles to develop robust processes, establish control strategies, facilitate technology transfers, and support regulatory submissions.

You will serve as a technical leader within cross-functional teams to ensure successful product commercialization and lifecycle management.