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The primary role of the Packaging Engineer in the Global Packaging Technology (GPT) group is to lead or assist in the development and testing of commercial packaging with a focus on global brand protection (GBP) initiatives including tamper evidence, chemical taggants, and serialization. This individual must be able to work independently to generate scientifically valid data and carry out routine analyses.
Author or support technical documentation for design requirements, engineering testing, qualification or validation protocols and reports, specifications, technical drawings, change control and GBP business requirements
Support technical artwork development process as necessary
Conduct routine testing on primary, secondary, and tertiary/distribution packaging using a wide array of test equipment and instrumentation
Record and analyze test data using basic statistics to effectively summarize results
Help manage external test facilities and provide direct oversight and guidance for testing including planning, procurement, and organization of test materials
Support implementation of GBP initiatives and serialization labels at packaging printers and/or internal or external manufacturing (CMO) in accordance with their processes and capabilities
Participate in technical audits at packaging printers as necessary
MINIMUM EXPERIENCE REQUIREMENTS:
6+ years packaging related experience
3+ years of experience within the pharmaceutical, biotechnology, or medical device industries
Strong understanding of cGMP environment
Working knowledge of packaging related standards and regulations for ASTM, EMA, FDA, GS1, ICH, ISO, ISTA, and USP
Lean and/or Six Sigma training is preferred
KNOWLEDGE & SKILLS:
Excellent written and verbal communication skills to communicate at all levels of the organization
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