_{09th October, 2025}

Our client in California is looking for a Softgel Manufacturing Engineer to join their team!

This is a remote/full-time/direct-hire position
Salary based on experience: $120k-140k
 
ESSENTIAL FUNCTIONS 
To accomplish this job, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodations may be made to help enable qualified individuals with disabilities to perform the essential functions. 
 
Process Optimization & Troubleshooting

• Improve softgel manufacturing processes for throughput, consistency, and quality.
• Troubleshoot issues such as:
  • Air bubbles in fill materials
  • Heterogeneous compounding and phase separation
  • Proper gelatin viscosity, fill weight variation, or drying consistencies
• Support and improve CIP (Clean-In-Place) systems for compounding and gelatin tanks to ensure sanitation and regulatory compliance.
• Monitor and optimize critical parameters such as temperature, viscosity, pH, and mixing speed.

Continuous Improvement: Kaizen, Six Sigma, Design of Experiments, and RCCA

• Optimization and continuous improvement of manufacturing equipment and processes.
• Implement continuous improvement initiatives using Lean Manufacturing and Six Sigma methodologies to increase productivity, reduce waste, and improve product quality.
• Use Six Sigma methodologies to identify and implement process improvements.
• Design and execute DOE (Design of Experiments) to optimize process parameters, material performance, and equipment settings.
• Conduct Root Cause and Corrective Action (RCCA) investigations using tools such as 5 Whys, Fishbone diagrams, and FMEA to systematically resolve recurring quality and process issues.
• Use data-driven analysis (e.g., Minitab, JMP) to drive decisions and validate solutions.
  
  

New Product Introduction & Scale-Up

• Collaborate with R&D and Quality to scale up new softgel products from pilot to full-scale production.
• Support process validation and technology transfer efforts for product launches and manufacturing readiness.
  
  

Plant Expansion & Equipment Integration

• Contribute engineering expertise to plant expansion projects, including equipment selection, facility layout, and new line installation.
• Support commissioning and qualification of new softgel machinery and systems.
• Integrate automation and process controls to improve efficiency and reduce human error in encapsulation and compounding.
  
  

Compliance & Documentation

• Develop and maintain process documentation, including SOPs, batch records, and validation reports.
• Ensure operations comply with cGMP standards, FDA requirements, and internal quality procedures.
• Participate in audits, deviation investigations, and CAPA processes.
• Maintain compliance with all health, safety, and environmental regulations, ensuring that all mechanical systems and processes adhere to industry standards.
  
  

Cross-Functional Collaboration & Leadership

• Create, update, and train the production team on Work Instructions(WI) following our GMP protocols.
• Be a subject matter expert in softgel manufacturing with continuous support of the production team to optimize the processes.
• Partner with production, quality, maintenance, and planning teams to drive improvements.
• Provide technical guidance to operators, technicians, and junior engineers.
• Lead or participate in continuous improvement teams focused on yield improvement, waste reduction, and throughput gains.
  
  

POSITION QUALIFICATIONS 

• Positive - Ability to view all situations with a positive attitude. 
• Innovative - Ability to look beyond the standard solutions and "think outside the box".
• Detail-Oriented - Ability to pay attention to the minute details of a project or task.
• Enthusiastic - Ability to bring energy to the performance of a task.
• Friendly - Ability to exhibit a cheerful demeanor toward others.
• Initiative - Ability to make decisions or take actions to solve a problem or reach a goal.
• Organized - Possessing the trait of being organized or following a systematic method of performing a task.
• Reliability - The trait of being dependable and trustworthy.

 
SKILLS & ABILITIES 
Education:

• A bachelor's degree in Chemical Engineering, Mechanical Engineering, Pharmaceutical Engineering, Food Engineering is a must.
• 3+ years of work experience in softgel compounding and encapsulation manufacturing is required.
• LEAN Certification (e.g, Green Belt / Black Belt) is required.

 
Experience: 

• 5+ years of experience in production and manufacturing engineering,
• Previous project management, cost saving, and Continuous improvement experience

 
Applicants must be authorized to work in the U.S.

We are an equal-opportunity employer. We do not discriminate in hiring or employment against any individual based on race, color, gender, national origin, ancestry, religion, physical or mental disability, age, veteran status, sexual orientation, gender identity or expression, marital status, pregnancy, citizenship, or any other factor protected by anti-discrimination laws.

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