Process and Package Engineer

Position Summary: The Process and Packaging Engineer will be responsible for seamless and efficient bulk pilot and fill line trials. Function as liaison between RID/Operations/Production to support formula development packaging, bulk and finished goods. This role is responsible for transferring lab formulas from lab to production, developing, and optimizing production processes that efficiently enable successful production run.

Essential Functions, Duties and Responsibilities Other duties may be assigned.

• Create manufacturing instructions by translating lab processes and observations into practical, scalable production procedures, including batch instructions and support for pilot and line trials.
• Perform upstream processing and ensure scalability during pilot development.
• Identify innovative technologies to improve efficiency, enhance quality, and reduce costs for both existing and new products.
• Lead and support line trials by tracking execution, identifying issues, adjusting processes, and communicating findings to stakeholders.
• Develop equipment specifications such as fill weight, torque, seal testing, crimping, and commercial run targets in partnership with Quality and Operations.
• Evaluate packaging suitability and component compatibility while considering equipment capabilities and production readiness.
• Assess packaging for NPD and changes to existing components, ensuring proper selection for each product.
• Coordinate packaging components with Operations, RID, and Quality Assurance.
• Support bulk pilot, first bulk, and fill runs, coordinating batching and filling activities and serving as technical liaison for OTC validation documentation.
• Create line trial protocols and manufacturing instructions that define clear, product specific process control parameters.
• Develop process and packaging workflows across all stages of the product lifecycle.
• Train Compounders and Supervisors on new processes and packaging procedures.
• Collaborate with RID scientists to ensure formulations meet release specifications and can be successfully scaled and filled.