Process Development & Formulation Engineer

Process Development & Formulation Engineer Job Title: Process Development & Formulation EngineerLocation: Oldsmar, FLDepartment: Process Engineering / R&DReports To: Director of OperationsEmployment Type: Full-Time Position Overview: We are seeking an experienced and innovative Process Development & Formulation Engineer to support the development, optimization, and scale-up of manufacturing processes and formulations across multiple dosage forms. This role serves as a critical bridge between R&D and Manufacturing by ensuring formulations are effectively transferred from development to full-scale production while maintaining product quality, process efficiency, and regulatory compliance. Key Responsibilities: Process Development and Optimization: Design, develop, and optimize manufacturing processes for product commercialization and scale-up. Analyze production workflows, equipment selection, and process efficiency to improve manufacturing performance. Implement Lean Manufacturing and Six Sigma methodologies to reduce waste and improve consistency. Lead process characterization, validation, and optimization activities. Formulation and Scale-Up: Support formulation scale-up activities for liquids, creams, gummies, tablets, powders, capsules, and OTC products. Conduct equipment compatibility assessments and production feasibility studies. Develop and refine batch records, SOPs, BOMs, and validation documentation. Lead technology transfer activities from R&D to Manufacturing. Production Support and Troubleshooting: Provide technical support and troubleshooting for manufacturing operations. Investigate process deviations, quality issues, and production inefficiencies. Collaborate with QA and Production teams to implement corrective and preventive actions. Support IQ/OQ/PQ validation activities and compliance initiatives. Cross Functional Collaboration: Collaborate with R&D, QA, Production, and external vendors to support manufacturing goals. Present technical findings, process improvements, and project updates to stakeholders. Support continuous improvement and operational excellence initiatives. Qualifications: Bachelor’s or Master’s degree in Chemical Engineering, Food Science, Pharmaceutical Sciences, Mechanical Engineering, or related field. Minimum 5 years of experience in process engineering and formulation development within pharmaceutical, nutraceutical, or cosmetic manufacturing. Experience with scale-up, technology transfer, and process optimization. Hands-on experience with production equipment including granulators, encapsulators, tablet presses, blenders, homogenizers, and gummy cookers. Knowledge of GMP, FDA, ISO, NSF, and OSHA regulations. Strong analytical, troubleshooting, and project management skills. Lean Six Sigma Green Belt or Black Belt preferred. Work Environment: Office and manufacturing production environment. Frequent interaction with production personnel and laboratory staff. Exposure to manufacturing equipment and pilot-scale operations. PPE required in production areas. Schedule and Benefits: Monday through Friday, 8:00 AM to 5:00 PM. Full-time salaried position. Medical, dental, and vision insurance. Paid time off and holiday pay. Professional development and training opportunities. Collaborative and innovation-driven work environment.