The Senior Packaging Engineer will work cross-functionally with Illumina Manufacturing, Marketing, Supply Chain, Quality, Regulatory, Product Development, and additional departments, as needed, to develop optimized, cost effective, and sustainable packaging for all Illumina products. Develops new package requirements and maintains quality of existing packages for all product groups. (consumables, instruments and spare parts). This position is responsible for designing, sourcing and qualifying all product packaging materials, shipping containers and product/packaging labels. Determines packaging requirements according to the nature of the product, cost limitations, legal requirements and the type of protection required, taking into consideration the need for resistance to external variables. Using appropriate tools, performs integrity analysis of packages.
Tasks and Responsibilities: Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Acquire and maintain a clear understanding of the technologies utilized in Illuminas products, parts, and services. Team leader on project teams responsible for developing package systems. Design and select primary and secondary packaging components and suppliers. Write specifications and technical reports for primary, secondary and tertiary packaging components. Coordinate and lead artwork/labeling development and approval process internally and with contract sites. Interface with Quality Group and external suppliers to conduct testing (including shipping studies) of packaging materials and packaged components to minimize product damage and ensure compliance with regulatory guidelines. Develop and implement Standard Operating Procedures for all aspects of packaging. Develop/apply lab procedures for evaluation of packaging solutions. Develop cold chain management systems including qualification and specification. Develop and qualify insulated shipping systems to keep products within specified temperature range. Oversee technical personnel as directed or requested. Other duties as assigned by the department manager.
All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
Preferred Educational Background: Requires a Bachelors/Masters degree or equivalent in packaging engineering or related discipline, and a minimum of 5 to 8 years related experience.
Preferred Experiential Background: Pharmaceutical/life science process and FDA regulated environment experience preferred. Knowledge and working application of FDA regulated environment, cGMP, and ISO 13485 requirements. Experience with secondary packaging equipment (ie capping, bag sealing equipment, cartoners, labeling equipment) design, application, and use is a big plus. Experience writing and executing validation protocols for packaging equipment and processes. Must have ability to analyze and resolve planning problems independently. Effective verbal and written English communication, analytical, and interpersonal skills are a must. Ability to interface well with cross-functional teammates is critical to success in this position. Six Sigma and Lean Manufacturing experience is preferred.
Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you have a disability or special need that requires accommodation, please contact us at ...@illumina.com. To learn more, visit: