Engineer I – KellyMitchell – Westlake Village, CA, USA
This position reports to “Principal Packaging Engineer” and is responsible to validate the packaging solutions used to ship products to assure product integrity and compliance.
The incumbent works closely with Global Distribution Quality, Global Logistics Validation, Packaging Design and Cold Chain Packaging Engineering to ensure packaging solutions are properly validated and adequately designed for the product and the shipping route, according to regulatory, operations, and customer requirements.
Essential Duties and Responsibilities:
• Packaging Validation
o Draft packaging validation protocols and the associated final reports for the thermal and physical integrity qualification of insulated shipping solutions.
o Work with Global Distribution Quality and the Principal Packaging Engineers to define the most appropriate validation strategy.
o Document and justify deviations as applicable.
o Initiate and manage change control tasks associated with insulated packaging changes.
o Manage activities related to the execution of the protocol:
– Preparation and shipment of the test samples
– Creation and approval of the purchase order (PO)
– Scheduling and communication with the testing laboratory
o Perform package requalification assessments as needed per Divisional requirements.
o Support other packaging studies and assessments in response to shipping deviations/issues.
o Maintain a database of package qualification data.
• Documentation Management
o Draft packaging related Standard Operating Procedures (SOPs) and material specifications.
o Perform periodic reviews of packaging related SOPs as needed per Divisional requirements.
o Submit and manage documents in the BPLM system.
• Working knowledge of, and ability to apply, ASTM, ISTA and ISO standards and procedures.
• Good understanding of the Cold Chain, ideally including expertise in cGMP.
• Good communication skills (with staff, colleagues, suppliers, and senior management), both oral and written.
• Ability to use critical thinking, problem solving skills, and sound technical knowledge to address, correct, and prevent issues.
• Medium to High skill level in MS office tools (Word, PowerPoint, Excel, Project, Access).
• Experience with Change Management in a GMP environment.
• Sensitivity to different peoples and cultures, as there are extensive dealings with people of varying cultural and socio-economic backgrounds.
• High Emotional Intelligence.
• Bachelor’s degree in Packaging, Material Science or Engineering, or 2-3 years related experience in a validation and quality systems environment.
• Work experience in Biopharmaceutical and/or highly regulated and compliance-focused industries, ideally with exposure to cold chain/temperature controlled products.
• Proficiency in English (both oral and written).