Packaging Engineer – Endeavor Consulting Group – Raritan, NJ, USA
The purpose of this job within our client global packaging engineering service of their Global Operations organization is to lead and/or assist in the design, development, testing, and support of clinical, commercial, and cold-chain packaging and shipping qualification. This individual will be responsible for designing, performing testing internally and coordinating any testing activities conducted externally. Design and development includes supporting the technical artwork development process.
Principal Accountabilities:
- Lead or assist in the design, development, material selection and testing of high-level, complex packaging projects from conceptual design through implementation. Design and development includes packaging primary and secondary packaging material research and selection and supporting the technical artwork development process.
- Perform routine testing on primary, secondary, and cold-chain packaging using a wide array of test equipment and instrumentation. Author notebook studies and reports from engineering testing activities and collect and present test data and results for formal qualification and validation activities. Manage and coordinate testing and inspection activities conducted at external test facilities. Help manage external test facilities and provide direct oversight and guidance for testing including planning, procurement, and organization of test materials.
- Author technical documentation related to packaging for design requirements, design verification, technology transfer, qualification or validation protocols and reports, and assessments based on comparability, manufacturability, suitability and risk. Support documentation management for global standards and policies as well as standard operating procedures, test methods, work instructions, specifications, and drawings.
- Provide technical oversight, support, and guidance for existing and new packaging components, systems, solutions, processes, and equipment. Participate in internal and external cGMP, quality, and technical audits as necessary
- Provide technical support and help conduct investigations related to packaging. Assume responsibilities for all necessary quality systems for change controls related to packaging as well as vendor change notifications, complaints, deviations, and CAPAs.
- Location US-NJ-Raritan
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.
Please send resumes to: Cathy.kane@endeavorcg.com
Requirements:
Qualifications
- Complete, in-depth understanding of all aspects of the product design and packaging materials to help develop primary and secondary packaging for GMP products.
- Experience in working in Biopharmaceutical or highly regulated and compliance industry,
- Cold chain/temperature controlled products knowledge experience is a nice to have
- 6+ years packaging related experience.
- 3+ years of experience within the pharmaceutical, biotechnology, or medical device industries.
- Experience working with external suppliers and contractors is highly desirable. Working knowledge of packaging related standards and regulations.
- Strong packaging material knowledge’s
- Blister pack, Carton for blister pack, Carton for vials and or syringes
- Education BS/BA degree is required. BS/BA in Packaging Science/Engineering is preferred.
- Lean and/or Six Sigma training is preferred.
- 3D CAD experience (Solid work application)
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.
