Engineer III, Packaging (9-12 Month Contract)
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Job Location:
Danbury, CT - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job 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.
Essential Duties:
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 other lower-level 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.
Design drug product packaging in support of the drug development process by identifying:
o Critical drug product attributes as defined by Development teams
o Commercialization requirements set by Marketing
o Regulatory needs supporting NDA submission review and approval
o 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.
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 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.
Generate written development and investigation reports in support of package components materials equipment and processes.
Responsible for observing all Company Health Safety and Environmental guidelines.
Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary.
Minimum Qualifications
BS Degree in Package Engineering with 7-10 years or MS with 5-7 years of related experience in package engineering in pharmaceuticals or the equivalent combination of training and experience.
Working knowledge of materials test methodology laboratory procedures and packaging equipment.
Strong organizational skills and ability to manage multiple responsibilities.
Knowledge of cGMPs and various regulatory aspects affecting pharmaceutical packaging development
Required Experience:
IC
About Company
Drawing on the legacy of innovator and humanitarian Alfred E. Mann, our team of passionate scientists, researchers, and professionals develops cutting-edge therapeutic products and technologies that help people take control of their health and live—fully humann.
