Principal Engineer, Packaging Engineering – Allergan – Irvine, CA, USA
In early 2015, Actavis completed the acquisition of Allergan. This combination united two growing, successful and profitable companies into a unique, global pharmaceutical company and a leader in a new industry model – Growth Pharma. In June 2015, the combined company changed its corporate name to Allergan plc and its stock ticker to NYSE: AGN.
Today, our nearly 30,000 talented global employees are creating an unrivaled foundation for long-term growth. We combine highly regarded brands and a best-in-class generics business with an enviable pipeline and lean, reliable operations to drive value for customers.
Join one of the world’s fastest growing specialty pharmaceutical companies!
At Allergan you will have the opportunity to thrive in a fast-paced, strategic environment where bold, innovative thinking isn’t just welcomed, it’s encouraged. Across all functions, we relish the opportunity to help our people fulfill their potential. Our rapid growth strategy means plenty of stretch assignments and opportunities to step into the spotlight.
Position Description
The Principal Engineer – Package Engineering is responsible for the design, coordination, development and implementation of packaging systems for the pharmaceutical, biological, eye care, skin care, and medical devices businesses. This individual applies sound scientific, engineering and current regulatory knowledge for the planning and execution of development projects. This incumbent executes and supervises scientific studies and manages laboratory activities. S/he manages the development of standardized test procedures, policies, and standards for the department.
The Principal Engineer – Package Engineering assures compliance with regulatory packaging requirements for both domestic and international distribution and be an effective contributor to CMC packages in a timely manner to meet worldwide cGMP registration requirements. This would include any ISO 9000 and or ISO 13485 requirements that need to be met. This individual must interface with other Allergan functions such as: Marketing, Regulatory Affairs, Quality Assurance, Manufacturing and Clinical. This incumbent is recognized as a technical Expert for packaging design, materials, processes, and problem resolution. Additional responsibilities may encompass direct or indirect supervision and training of exempt and non-exempt technical personnel. S/he will have responsibilities that may require recommendation and control of capital expenditures as defined in the capital appropriation budget.
The Principal Engineer – Package Engineering will design, evaluate, and implement world class packaging for pharmaceuticals, biologics and devices through competitive benchmarking and customer feedback. Designs and materials select should meet requirements set for toxicology, microbiology, chemistry, as well as migration and WVTR as required. This individual represents department in project team meetings and works closely with other Pharmaceutical Development groups, Research Microbiology, Regulatory Affairs, Project Management, Manufacturing, Quality Control, and Marketing to meet project timelines and objectives. This incumbent, within Pharmaceutical Sciences, schedules and organizes and plan meetings to ensure smooth operation and timely review of projects. S/he develops and maintains a current in-depth knowledge of global regulatory submission requirements, GLP/GMP requirements & (ISO 9000 where required), and maintains up to date knowledge of state of the art solutions and device packaging strategies though trade journals, seminars, and trade shows. S/he will evaluate alternate materials, closures, labels and processes for improved barrier and manufacturing efficiency.
Qualifications
A B.S. Degree in Packaging, Mechanical, or Materials Engineering with minimum 10 years of experience is required; OR, an advanced degree with minimum 8 years of experience in the Pharmaceutical, Biologics or Medical device field for package design and development is required. Experience with primary container closure development for solid oral dosage forms, pediatric packaging and associated manufacturing and filling processes preferred. Advanced classes in subject field preferred as is specialization in barrier technology, aseptic processes. Experience in container/closure systems to include bottles, tubes, vials, syringes, pouches, etc. as well as related filling systems for sterile and aseptic processes required. Demonstrated experience in packaging automation and manufacturing to include FFS, Plastic molding, and assembly processes such as RF, US, heat and welding preferred. Working knowledge of GMP, ISO, FDA, NSTA, ISTA, ASTM and other regulatory issues relating to Pharmaceutical and medical device packaging required. Working knowledge of Design Controls and how they would apply to Combination products from a packaging perspective and ISO 13485 and 14971 for Risk management preferred. Experience in Cold chain shipping requirements including validation preferred. Demonstrable track record of achievement from package design and materials selection, through criteria evaluation, validation, and implementation required. Working knowledge of “Design of experiments” and other analytical tools required. Experience in direct supervision of technical staff a plus. A team attitude with positive outlook is a must and required as is the ability to work with cross functional teams including R & D, Manufacturing, Marketing, Regulatory, etc. Ability to manage multiple, complex projects required as is proactively assess/identify new opportunities to enhance impact of package development on cross-functional projects and teams required. Ability to assess technical opportunities as needed and to make appropriate assessments and recommendations to management required as is design for manufacturability and scalability required. Support of Manufacturing in troubleshooting production problems required. Project management competencies in budgeting and resource planning and management required. The successful candidate is required to have good communication skills, both written and oral and ability to prepare technical reports and presentations. Creation of schedules and tracking of tasks to these schedules required as is proficiency in MS Office and project management programs required. This position is located in Irvine, CA and may require both domestic and international travel up to 25% of the time.
