Senior Process Engineer - GMP Manufacturing & Validation

ABBVIE; Branchburg Township (NJ); On-site; USD 79,000 - 141,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie is seeking an experienced process engineer to lead validation activities and support manufacturing for multiple product lines. Responsibilities include process and equipment qualification, data-driven problem solving, and cross-functional collaboration with development and operations teams to ensure compliant, efficient production.

The role emphasizes engineering design, process optimization, and involvement in change control while maintaining high standards of quality and safety within a

Qualifications

• Bachelor’s degree in Engineering, Science, or closely related discipline is desired, with 5+ years of significant engineering/operational experience.
• Strong technical knowledge and application of concepts, practices, and procedures.
• Interacts well with diverse groups within engineering and maintains relationships with collaborators.

Responsibilities

• Lead process engineering activities in product lines, including Process Validation, Cleaning Validation, IQ/OQ/PQ, investigations to address root cause.
• Support and monitor Production to troubleshoot material, process and equipment problems including product loss and inefficiencies with data analysis.
• Provide technical evaluations and support for Engineering Change Orders and Supplier Changes.
• Design, build and qualify fixtures, machines, or equipment to facilitate manufacturing capability.
• Support integration of new products into manufacturing, provide input on materials, processing and cost.
• Assist in validation of new/revised processes and equipment, ensuring compliance with standards.
• Design and execute engineering studies to test hypotheses.
• Apply scientific and technical knowledge to projects and may supervise others.

Skills

Process engineering

Data analysis

Root cause analysis

IQ/OQ/PQ

Manufacturing equipment

Cross-functional collaboration

Communication skills

Problem solving

Financial systems

Education

Bachelor's degree in engineering or related

Post-graduate degree preferred

Tools

Statistical tools

Data acquisition systems

Job description

AbbVie is seeking an experienced process engineer to lead validation activities and support manufacturing for multiple product lines. Responsibilities include process and equipment qualification, data-driven problem solving, and cross-functional collaboration with development and operations teams to ensure compliant, efficient production.

The role emphasizes engineering design, process optimization, and involvement in change control while maintaining high standards of quality and safety within a