What are the responsibilities and job description for the Sr. Process Development Engineer position at AbbVie?
Primary Function/ 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
Education:
- Bachelor’s, Master's or PHD in Engineering or related field,
- Bachelor’s degree with 8 years, Master's degree with 6 years of PHD with 3 years in Engineering or related field of process development experience in a regulated industry
Job Skills/ Experience Required
- 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
Cognitive Skills:
- Reviews and approves other professionals’ analysis; leads problem solving teams; Begins to incorporates both technical knowledge and business acumen when solving problems
Ownership
- Reviews and approves decisions of other professionals and offers innovative solutions; designs and conducts novel experiments
Influence/ Leadership:
- Acts as a technical advisor; Interfaces at all levels regarding technical content
- Acts as engineering lead and mentors other team members
Decision Making/ Impact:
- Guides the successful completion of major programs and may function in a project leadership role; results have considerable impact on major organizational objectives
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. 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 protected veteran, or any other legally protected group status.
About the Company:
AbbVie