Senior Packaging Engineer

Description:

Duties: Use experience with: primary, secondary and tertiary packaging component development and qualification; primary component manufacturing processes and materials; container and closure design and ability to interpret molded parts drawings; blister packaging and thermoforming processes and ability to interpret blister design drawings; secondary and tertiary packaging materials and design; lab testing equipment including RAM Optical, Optical Comparator, Magna Mike, Instron, vacuum leakage, and drop and vibration test equipment; ASTM and ISTA ship testing requirements; packaging qualification and validation methods (IQ/OQ/PQ); child resistant packaging test requirements per 16 CFR 1700; project management; change control to serve as subject matter expert (SME) for technical packaging matters and package development activities. Drive package development projects to support product launches and life cycle management activities. Support packaging technical transfer activities for changes to packaging and drug manufacturing sites. Facilitate and support business continuity projects to source and qualify new packaging components, materials and/or suppliers to reduce component supply risk. Select and qualify secondary and tertiary designs and materials to effectively maintain product integrity from product packaging through distribution to the end user. Develop die line drawings for the graphic design of printed packaging components for regulatory filings, commercial product launches and packaging changes. Support Regulatory filing activities by providing and reviewing content for filings. Develop and execute Human Factors Use studies. Manage change control for packaging changes. Understand and collaborate with Anti-Counterfeiting and Tamper Evidence (ACTE) team regarding anticounterfeiting, tamper evidence and temperature assurance packaging. May telecommute 50% of time from anywhere in the US.

Requirements: Bachelor's degree (or foreign equivalent) in biological engineering, packaging engineering, engineering or related and 2 years of experience reflecting demonstrable ability in the skill set described above (experience may precede degree).