Senior Process Development Engineer

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 - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

Join Our Process Development Team

At AbbVie's Process Development team, we are dedicated to pioneering advancements in the field of tissue products. Our highly collaborative group focuses on developing innovative manufacturing processes that support both clinical and commercial applications. We're seeking driven and talented individuals to join us in transforming scientific discoveries into tangible health solutions.

Role: Senior Process Development Engineer

• Designs and develops processes for manufacturing clinical and commercial tissue products, using statistics-based experimentation and principles of process excellence
• Investigates and evaluates existing technology; designs and implements new methodologies, materials, machines, processes, or products
• Conducts appropriate studies to demonstrate the ability of the product/device to function as intended (i.e., verification and validation process)
• Develops study protocols, technical reports, new process Standard Operating Procedures (SOPs), batch records, and other documents as required, including the necessary documentation to support regulatory filings such as 510k, IDE, and PMAs
• Identifies outside vendors and consultants to ensure the delivery of raw material, equipment, supplies, or services needed to meet scheduled timelines
• Interfaces with various departments to ensure processes and designs are compatible for new product technology transfer
• Serves as technical leader and establishes project level timelines with project teams
• Provides technical support to manufacturing and quality as needed
• Monitors the performance of processes and equipment and makes recommendations for continuous improvement

Qualifications

Minimum Requirements:

• Bachelors Degree + 7 or more years of experience OR Masters + 4 or more years of experience OR PhD + 2 or more years of experience
• Engineering Degree
• Process Engineering experience
• Experience in pharma or med device industry

Preferred Experience:

• Experience with tissue, natural products or any material that is prone to variability

Other Required Skills:

• Ability to exercise judgment within defined procedures and policies to define appropriate actions in developing methods, techniques and evaluation criteria

• Demonstrates advanced engineering principles and practices; challenges engineering designs

• Provides the highest level of statistical support to project teams, function or department

• Communicates at all levels and delivers highly technical information in a clear and easy-to-understand way

Additional Information

Applicable only to applicants