Process Development and Formulation Engineer

Job Description

Job Description

About the Role
The Process Development and Formulation Engineer plays a critical role in optimizing manufacturing processes and scaling formulation technologies across liquids, creams, gummies, tablets, powders, capsules, and over-the-counter (OTC) products. This position ensures the seamless transfer of product formulations from research and development to full-scale production. Leveraging process engineering, formulation science, and continuous improvement methodologies, the engineer drives manufacturing efficiency, cost reduction, and regulatory compliance in a high-performance production environment.

Responsibilities:

• Design, develop, and optimize manufacturing processes for efficient scale-up and production readiness
• Conduct process characterization, workflow analysis, and equipment selection to improve production efficiency
• Lead technology transfer activities, ensuring robust scale-up of formulations for multiple dosage forms
• Analyze and enhance process workflows using Lean Manufacturing tools such as Value Stream Mapping and Kaizen
• Apply Six Sigma methodologies, including DMAIC and DMADV, to improve quality, yield, and consistency
• Develop and refine batch records, standard operating procedures (SOPs), and process validation documentation
• Perform or oversee IQ, OQ, and PQ validations to ensure process compliance and performance
• Support troubleshooting of production issues related to quality, yield, and throughput
• Draft and maintain manufacturing documentation including BOMs, routings, and operator instructions
• Collaborate cross-functionally with R&D, Quality Assurance, and Operations to align on product and process requirements
• Interface with vendors and suppliers to enhance equipment capability and raw material performance
• Present technical findings and process improvements to internal and external stakeholders
• Ensure compliance with GMP, FDA, NSF, ISO, and OSHA regulations across all manufacturing processes

Qualifications:

• Bachelors or masters degree in Chemical Engineering, Pharmaceutical Sciences, Food Science, Mechanical Engineering, or a related discipline
• Minimum of 5 years of experience in process development and formulation within nutraceutical, pharmaceutical, or cosmetics industries
• Proven expertise in scaling up and optimizing formulations for liquids, creams, tablets, powders, capsules, gummies, and OTC products
• Proficiency in process engineering equipment such as tablet presses, granulators, encapsulators, mixers, and gummy cookers
• Strong background in formulation science across solid, semi-solid, and liquid dosage forms
• Hands-on experience with technology transfer from R&D to manufacturing environments
• Skilled in process optimization, root cause analysis, and statistical tools including Minitab and FMEA
• Knowledge of regulatory frameworks including GMP, FDA, NSF, ISO, and OSHA
• Project management and problem-solving abilities in a fast-paced production setting

Desired Qualifications:

• Lean Six Sigma Green Belt or Black Belt certification
• Certification in GMP or FDA regulatory compliance
• Experience drafting design transfer documentation and validation protocols
• Familiarity with Design for Manufacturing (DFM) principles
• Experience leading cross-functional project teams in product commercialization initiatives
• Strong communication skills with the ability to convey technical information to diverse audiences