Principal Process Engineer - Vitamins and Supplements
Melaleuca Inc.
Overview Principal - Process Engineer The Principal Process Engineer performs a wide variety of technical tasks in support of specific Melaleuca new or existing products, including personalcare, homecare, dietary supplements and other OTC ingestible products, under the supervision of the Sr. Director of Process Development. These tasks are highly specific and usually require the use of quantitative methods and the application of technical judgment to assist in the development of new products or to troubleshoot problems with existing manufacturing, formulation, or other technical issues. Requires excellent project management skills is to keep new launches on track, with minimal in-house tools Responsibilities Deliver robust and efficient processes, scale-up and technology transfer of formulations and processes to Manufacturing. Work with manufacturing to scale up all products, improvement processing steps and formulation for optimized manufacturing and product delivery. Establish blend sizes, protocols, and testing requirements for scale up as well as production. Provide technical support and expertise, ensuring a smooth and efficient process development, scale up and manufacturing transfer of several dosage forms including capsules, tablets and powders. Perform data gathering, root cause analysis and performance trending to develop appropriate process control for key parameters affecting product performance. Prioritize and implement process change requirements based on the critical project needs. Demonstrate experience with development and process scale up of capsules, tablets and powders. Lead change management system with process changes and new processes. Collaborate with cross-functional teams, including Manufacturing and Quality to develop and implement process improvements that ensure optimized and efficient manufacturing operations that are compliant with regulatory requirements and industry best practices. R&D GMP training and management Implement GMP for Dietary supplements, Food as well as Pharmaceutical products. Develop and formulate to meet pre-determined goals. Able to research materials and provide scientific reviews. Formulate capsules, tablets, and softgels for global market. Evaluates materials for quality and use in formulations. Includes alternate sourcing for price optimization. Enters value data into database that contains all applicable information of raw ingredients, blends, and formulas that go into products. Updates and scientifically evaluates all data imputed into database. Develops and maintains specifications for all Melaleuca products. Develops and maintains raw ingredient specifications for components of products. Travels to suppliers to conduct development & process scale-up, audits, and testing as needed. Work effectively with external co-manufacturing partners in the formulation and process development. Perform planning, monitoring and documentation of plant trials at outside manufacturers for successful commercialization of new products. Keep accurate records of lab work, documentation of ingredients used, and formulation modifications. Project Management Oversee all applicable technology transfers. Understand and work within DSHEA and Pharmaceutical regulations. Critically evaluate plant / facilities to determine best relationship. Work against COGs budget to find savings in formulation, manufacturing, and process Trouble shoot lab to plant issues, make suggestions for improvement. Qualifications Bachelor of Science degree in Chemical Engineering or related field with a minimum of 10 years’ experience in Supplement Formulation, Process Development & Manufacturing Scale Up. Master’s degree in chemical engineering or related field with a minimum of 7 years’ experience in Supplement Formulation, Process Development & Manufacturing Scale Up. Other Science degrees with experience in plant and process development process will be considered Demonstrate proficiency with structured methodologies such as Quality by Design, Process Control Strategies and Good Engineering practices. Additional Chemical Engineering background and/or manufacturing related experience preferred. Previous work experience in consumer products companies is preferred. Knowledge of commonly used lab instruments (e.g. balance/scales, calipers, etc #J-18808-Ljbffr Melaleuca Inc.
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