Packaging and Shipping Specialist
Location: San Diego, CA
Name: Alere, Inc.
Work can be done from San Diego, CA or Scarborough, ME
The Active Consumables Transfer (ACT) Packaging and Shipping Specialist manages a wide variety of technical tasks and projects in the development of new products and packaging processes. The Packaging and Shipping Specialist will consult on the robustness of packaging and shipping requirements and qualification of raw materials as well as in-process requirements. Further, the Specialist will assist the product development team to secure high-quality materials through material specifications with the aids of advanced analytical packaging and shipping characterizations. In addition, the specialist will actively participate in selecting and qualifying material suppliers with the aim of achieving predictable product performance and cost containment. This individual will be a leader within the ACT team and a key member of Alere medical device product development and operation teams.
- Accountable for the development and implementation of packaging for existing and new medical products and rapid diagnostic devices with a focus on cardio metabolic disease, infectious disease and toxicology.
- Leads the improvement and standardization of packaging and shipping on existing products with focus on performance and cost effectiveness.
- Actively collaborate with Packaging, shipping and labeling peers within the organization to identify and implement best practices, packaging, shipping and processes.
- Participate on cross-functional, cross-site project teams focusing on packaging, shipping technology and processes improvements
- Utilize knowledge of FDA and ISO requirements related to packaging, shipping and labeling, ensuring robust package validation and qualification
- Draft technical documentation including packaging and shipping testing protocols and validation associated with the qualification and release of packaging and shipping designs
- Will be responsible for leading and participating in the design, integration, installation, and start-up of packaging lines.
- Responsibilities will require engineering experience at the leadership and working levels of packaging, process, controls, equipment procurement, installation, and start-up.
- Qualified candidates will have a proven track record in budget, scope, and schedule management, client interaction, and contractor supervision.
- Working knowledge of automation and PLC-based systems is also desired.
- Must have good understanding of medical device validation requirements associated with packaging equipment on a global scale.
- Needs to have project management, self-directed skills to drive projects and solutions through completion.
- Must have strong understanding related to engineering documentation lifecycle involving packaging and shipping systems.
- Develop plans to establish proof of shelf life, accelerated and real time for packaging and shipping requirements.
- Coordinate projects and deadlines working with program lead to ensure all new product and package improvement deadlines are met.
- Serve actively in the identification of suppliers, testing and approving materials, including liaison with the vendors.
- Bachelor's degree in Mechanical, Industrial, Manufacturing, or Electrical Engineering preferred, but consideration will be given to other engineering or technical degrees based on relevant experience.
- 8+ years of pharmaceutical and or medical device project engineering and/or project management experience.
- Special knowledge requirements include biopharmaceutical and medical device process and facility design approaches, plus a solid understanding of cGMP requirements.
- Must have extensive expertise relevant to high speed automation packaging.
- Must be able to work collaboratively and build effective relationships with engineering team, operations, R&D, vendors, facility operations, quality assurance, and validation departments.
- Candidate must possess good communication and interpersonal skills, and have the ability to interact with all levels of management, client, and vendors.
- Strong organizational skills, oral and written communication and team attitude.
- Knowledgeable in ISO, ASTM, ISTA standards related to packaging.
- Solid proficiency in MS Word, Excel and statistical analysis software
- Familiarity with FDA quality assurance requirements for design and manufacturing.
- Ability to travel up to 25%, both domestic and international.
- Desired/Preferred Qualifications
- Certified Packaging Professional (CPP) preferred.
- Experience with ethylene oxide, steam, liquid chemical, and radiation sterilization methods
- Experience with Design for Lean Sigma (DFLS), Design for Manufacturability (DFM), process development and design of experiments (DOE) methodology Experience with Design Verification and Process Validation.
- Experience with MiniTab, Microsoft Project, Solidworks, MatrixOne, Agile, QAD. and SAP software.