Process Development and Formulation Engineer

1 Days Old

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
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Location:
Akron, OH, United States
Category:
Architecture And Engineering Occupations

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