Process Development Engineer

The Process Development Engineer IV is responsible for responsible for 1) serving on Concept and Product Development projects as a Process Development representative 2) providing hands-on technical and scientific leadership, 3) providing SME (Subject Matter Expert) support for existing products, 4) identifying and evaluating novel technologies during development of new tissue products/processes, 5) work with Operations Engineering during development and transfer of new technologies to the Production floor. Key Responsibilities 

• 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)
• Develop 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 make recommendations for continuous improvement

Experience Required:

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

• Ability to act under limited supervision to determine methods and procedures on new assignments

• Ability to leverage statistics, analysis, simulation and experimentation in the design and development process

• Demonstrated ability to communicate effectively both verbally and in written format

• Experience with Microsoft Office applications including Word, Excel and Outlook

Cognitive Skills:

• Completes analysis of root causes and makes recommendations without supervision; reviews other professionals’ analysis; leads problem solving teams

Ownership/Accountability:

• Every employee has a personal responsibility to commit to the AbbVie Vision, to engage and align with the AbbVie Strategic Imperatives, and to consistently execute in accordance with the AbbVie Operational Pillers and AbbVie Ways of Work.

• Works as a professional lead or team member; carries complete project load including the review and recommendations of other professionals

Influence/Leadership:

• May be required to support Cross Functional Teams and costs improvement projects

• Interfaces with a ride range of internal and external customers, including senior management; communicates on behalf of the department.

Decision Making/Impact:

• Contributes to the completion of specific programs and projects; results have considerable impact on schedules, programs and resource allocation

Minimum Qualifications:

• Bachelor’s degree in Engineering or related field with 7-9 years process development experience in a regulated industry

• Preferred: Master’s degree in Engineering or related field with 4-6 years experience or PhD with 0-2 years’ experience

 

AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.