Engineer III, Packaging Technology

2 weeks ago

Danbury, United States BioCT Innovation Commons Full time

At MannKind our employees are our number one asset, and we continue becoming a tight-knit community where each of us plays a critical role in our collective success. Committed to diversity, at MannKind we depend on a rich blend of ideas, backgrounds, and working styles in our quest to change the world for the better.

Position Summary

Responsible for Package Technology projects necessary to design, develop and transfer cost effective and sound packaging for pharmaceutical products. Determines packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of protection required, considering need for resistance to such external variables as moisture, corrosive chemicals, temperature variations, light, heat, handling and tampering. Works on complex problems in which analysis of situation 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. May determine methods and procedures on new assignments and may provide guidance to personnel Interacts in a team environment as part of the development, transfer and launch project structures, as well as required to work independently on the technical and regulatory tasks necessary to support corporate and team goals.

Primary Responsibilities

Design drug product packaging in support of the drug development process by identifying: Critical drug product attributes as defined by Development teams Commercialization requirements set by Marketing Regulatory needs supporting NDA submission, review and approval. Production efficiencies and standards as necessary. Develop packaging technologies using engineering principles and scientific analysis to collect and synthesize data relating to package and drug product performance. Implement package design solutions in a commercial environment, by leading & coordinating project activities, including equipment selection, procurement and qualification and logistics associated with contract packaging sites. Support clinical supply activities by designing appropriate drug product packaging. Scale up packaging technologies to production by compiling and executing the necessary technical and financial plans. Write, create and establish regulatory and purchasing specifications for packaging requirements (components, in process controls) based upon development and transfer activities. Coordinate and participate in the launch activities related to packaging which are required to support new product introductions. Lead and participate in project teams as required utilizing good communication, analytical, organizational and leadership skills. Generate written development and investigational reports in support of package components, materials, equipment and processes. Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary.

Required Skills & Experience

This position requires a Master degree or foreign equivalent in Industrial Engineering, Package Engineering or related field and 2 years of work experience in Packaging engineering, Pharmaceutical Sciences, or closely related occupation.

SPECIFIC SKILLS :

Must possess expertise/ knowledge sufficient to adequately perform the duties of the job being offered. Expertise/ knowledge may be gained through employment experience or education. Such expertise/ knowledge cannot be "quantified" by "time." Required expertise/ knowledge includes: • Materials test methodology, such as Physical testing including dimensional analysis of packaging materials. • Laboratory procedures: Conduct calibration of laboratory instruments according to written procedures. Follow written laboratory SOPs for documenting test results and generating summary reports. • Packaging/lab equipment such as calipers, gauges. • cGMP and Regulatory aspects: Recycling standards and environmental factors • Ability to manage multiple responsibilities.

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