This position is a key member of the Aziyo Biologics team and as such is involved in executing the Company’s short- term goals and objectives as it relates to packaging process evaluation, troubleshooting, support, and validation of in-house packaging, labeling, and sealing equipment.
Position reports to the Manager, Engineering
Essential Duties & Responsibilities
• Provide leadership and interface for Packaging and packaging equipment technologies.
• Define packaging processes for new products and presentations including selection of materials, specification of primary, secondary and tertiary packaging, and the package assembly process.
• Provide technical support for on-going production packaging/labeling processes, tools and software including assembly/sealing equipment and automation.
• Participate in process and product development activities ensuring that packaging/production processes and equipment are taken into consideration.
• Provide guidance on the development of internal test methods for package suitability and integrity.
• Manage third-party contractors in the execution of packaging studies.
• Identify and cost options for packaging/labeling/sealing equipment with consideration to product standard cost targets and capacity demands.
• Provide detailed engineering analysis and documentation in the management of material disposition, process updates, non-conformances and CAPA as related to packaging and the packaging process.
• Contribute to continuous improvements in overall product cost and quality.
• Partner with Manufacturing to develop lean principals to implement solutions for product packaging, labeling and sealing/assembly.
• Conduct, coordinate and aid in formal Process Validations including protocol development and execution.
• Follow established procedures to perform detailed, accurate, and compliant engineering documentation for PFMEA, Equipment Installation, Qualification and Validation activities.
• Application of statistical and analytical methods such as SPC, SQC and DOE.
• Bachelor of Science degree in Packaging Science or Other Engineering discipline
Experience and Skills
• 2-5 years applicable packaging experience
• Experience in packaging engineering in tissue products, medical devices, pharmaceutical or related industry.
• Knowledge of cold-chain process is a distinct advantage.
• Must be able to perform all job duties and physical requirements within the work environment.
• Excellent organizational skills, with the ability to handle multiple priorities and deadlines.
• Strong communication, manufacturing process, product industrialization and leadership skills.
• Solid design, troubleshooting and presentation skills.
• Knowledge and Experience with packaging, assembly and manufacturing methods/equipment.
• Knowledge and Experience with packaging material process and testing.
• Must be both a team player and able to work independently.
• Demonstrates a high concern for detail, accuracy, and compliance to Company and Corporate policies and procedures.
• Must be a self-starter and demonstrate a commitment to process improvement.
• Ability to exercise judgement, problem solve and work well with cross-functional teams.
• Service oriented with meticulous attention to detail.
• Works well under pressure with strict deadlines.
• Must have the ability to lift 50 lbs. or more.
• Some operations require bending, standing long hours, pushing and/or pulling objects to a machine or/on a cart.
• Ability to distinguish colors