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Job DescriptionJob Descriptionn

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:

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

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

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