Process Development and Formulation Engineer

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

• Bonus
• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance