Process Development & Formulation Engineer in Oldsmar, Florida at Eagle Labs, Inc

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.