Sr. Project Engineer, Packaging – PACKSTAFF LLC – Southern California, USA
Responsible for the design, coordination, development and implementation of packaging systems for the pharmaceutical, biological, eye care, skin care, and medical devices businesses. Applies sound scientific, engineering and current regulatory knowledge for the planning and execution of development projects. Executes and supervises scientific studies and manages laboratory activities. Manages the development of standardized test procedures, policies, and standards for the department.
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.
Position must interface with other Company functions such as: Marketing, Regulatory Affairs, Quality Assurance, Manufacturing and Clinical.
Recognized as a technical Expert for packaging design, materials, processes, and problem resolution.
Desired Skills and Experience
Essential Skills and Abilities:
- A team attitude with positive outlook is a must.
- 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 package development on cross-functional projects and teams.
- Ability to assess technical opportunities as needed and to make appropriate assessments and recommendations to management.
- Design for manufacturability and scalability.
- Support of Manufacturing in troubleshooting production problems.
- Project management competencies in budgeting and resource planning and management.
- Good communication skills, both written and oral. Ability to prepare technical reports and presentations.
- Creation of schedules and tracking of tasks to these schedules.
- Willingness and ability to travel both domestic and international up to 25% of the time.
- Proficiency in MS Office and project management programs.
Education and Experience:
- B.S. Degree in Packaging, Mechanical, or Materials Engineering with minimum 8 years of experience or an advanced degree with minimum 6 years of experience in the Pharmaceutical, Biologics or Medical device field for package design and development.
- Experience with primary container closure development for biologics (PFS, vials, injectors) and associated manufacturing and filling processes preferred.
- Advanced classes in subject field preferred. 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.
- Demonstrated experience in packaging automation and manufacturing to include FFS, Plastic molding, and assembly processes such as RF, US, heat and welding.
- Working knowledge of GMP, ISO, FDA, NSTA, ISTA, ASTM and other regulatory issues relating to Pharmaceutical and medical device packaging.
- 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.
- Experience in Cold chain shipping requirements including validation.
- Demonstrable track record of achievement from package design and materials selection, through criteria evaluation, validation, and implementation. Working knowledge of “Design of experiments” and other analytical tools.
- Experience in direct supervision of technical staff a plus.
- Candidates must be qualified to work in the US. No sponsorship available at this time.