Process Development & Formulation Engineer
Job Title: Process Development & Formulation Engineer
Location: Oldsmar, FL
Department: Process Engineering / R&D
Reports To: Director of Operations
Employment 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.
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