Principal Engineer, Device and Packaging Engineering

About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Summary

The Principal Engineer, Device and Packaging Engineering within the Combination Product Development organization will serve as a technical expert for container closure integrity, filling and crimping processes, and material science. He/she will be responsible for the design, development, coordination, and implementation of packaging systems across AbbVie's portfolio. 

You will join a diverse team of engineers and scientists with the opportunity to collaborate across many functions toward the development of world-class combination products.

Responsibilities:

• Design, develop, coordinate, and implement packaging systems for the pharmaceutical, biological, eye care, skin care, and medical aesthetics businesses
• Apply sound scientific, engineering and current regulatory knowledge for the planning and execution of development projects
• Execute and supervise scientific studies and manages laboratory activities
• Manage the development of test methods, policies, and standards for the department; 
• Assure compliance with regulatory requirements for both domestic and international markets and is an effective contributor to CMC teams 
• Partners with regulatory leads to meet worldwide registration requirements. 
• Represents department in project team meetings and works closely with other Pharmaceutical Development groups, Microbiology, Regulatory Affairs, Project Management, Manufacturing, Quality Control, and Marketing to meet project timelines and objectives.  May lead Device Development sub-team for one or more development projects.
• Oversight of external partners; manages vendors and CMO’s in both development of new products, and manufacturing activities.
• Develops and maintains a current in-depth knowledge of global regulatory submission requirements, GLP/GMP requirements and maintains up to date knowledge of state-of-the-art solutions and packaging development strategies though trade journals, seminars, and trade shows.
• Responsibilities may require recommendation and control of capital expenditures as defined in the capital appropriation budget
• Additional responsibilities may encompass direct or indirect supervision and training of exempt and non-exempt technical personnel.

Position interfaces with other AbbVie functions such as: Operations, Marketing, Regulatory Affairs, Quality Assurance and Clinical. 

Qualifications

Willingness and ability to travel both domestic and international up to 25% of the time.

Education and Experience:

• B.S. Degree in Plastics, Materials, or Mechanical Engineering with minimum 10 years of relevant experience or an advanced degree with minimum 8 years of relevant experience
• Experience with package design and development in the Pharmaceutical or Biologics field preferred.
• Advanced classes in subject field preferred.
• Experience in direct supervision of technical staff a plus.
• Demonstrable track record of achievement in packaging development and materials selection, through criteria evaluation, validation, and implementation. 
• Demonstrated experience in packaging automation and manufacturing to include FFS, Plastic molding, and assembly processes such as RF , US , heat and welding.

Skills / Knowledge:

• Expertise with primary container closure development for pharmaceuticals, biologics and associated manufacturing and filling processes required, with focus on pre-filled syringes.
• Experience in container/closure systems to include bottles, tubes, vials, pouches, etc. as well as related filling systems for sterile and aseptic processes.
• Sklled with engineering tools like CAD, FEA, statistical and data analysis.
• Experience in Cold chain shipping requirements including validation.
• Working knowledge of Design Controls and Risk Management methodologies and their application to combination products from a device and packaging perspective.
• Experience with Design for Manufacture and scalability.
• Working knowledge of DoE and other statistical tools.
• Working knowledge of GMP, ISO, FDA, NSTA, ISTA, ASTM and other regulatory standards relating to Pharmaceutical, Biologics and medical device packaging.

Essential Abilities:

• A team attitude with positive outlook is a must.
• Good communication skills, both written and oral.  Ability to prepare technical reports and presentations. 
• Able to work with cross functional teams including R & D, Manufacturing, Marketing, Regulatory, etc.
• Ability to manage multiple, complex projects.
• Proactively assess/identify new opportunities to enhance impact of packaging development on cross-functional projects and teams.
• Ability to assess technical opportunities as needed and to make appropriate assessments and recommendations to management.
• Support of Manufacturing in troubleshooting production problems.
• Project management competencies in budgeting and resource planning.
• Creation of schedules and tracking of tasks to these schedules. 
• Proficiency in MS Office, MS Project, as well as engineering packages Solidworks.

Significant Work Activities
N/A
Travel
Yes, 25 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.