Process Engineer — Validation, Scale-Up & CAPA

Capsum kkt; Del Valle (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Capsum KKT is seeking a Project Engineer for a full-time role at our U.S. site to own process performance, lead investigations when batches go out of spec, drive validation, and ensure robust scale-up for new formulas.

You will collaborate with Quality, Compounding, Production, Maintenance, and R&D teams to optimize processes and support day-to-day manufacturing. The ideal candidate brings 5+ years in process engineering, hands-on experience with filling and packaging lines, and strong

Qualifications

• 5+ years in a process engineering or similar role.
• Bachelor's degree in Packaging, Mechanical, Industrial, Manufacturing or Chemical Engineering (or related field).
• Experience launching new products on filling and packaging lines, including change parts, tooling, and line trials.
• Comfort working with cost data and holding projects to budget targets.
• Excellent oral and written communication skills and ability to communicate with cross functional stakeholders and external agencies. Team player with ability to work across functions, cultures and disciplines.
• Positive and constructive attitude. Be accountable by displaying high levels of integrity.

Responsibilities

• Lead and work with the Quality Team on process related out-of-specification (OOS) and deviation investigations from start to finish, including root cause analysis and CAPA.
• Owning process validation activities, including protocols, execution, and final reports
• Supporting equipment qualification (IQ/OQ/PQ) for new and modified equipment
• Defining critical process parameters and building control strategies that keep batches consistent
• Supporting scale-up and tech transfer of new formulas from R&D into production
• Set bulk hold times and storage conditions, and define fill windows (temperature, viscosity) so bulk arrives at the filler ready to run
• Using data to spot trends early and fix issues before they turn into OOS results
• Improving the performance of our batch vessels, pumps, valves, piping, and transfer lines
• Leading or supporting capital projects and continuous improvement work
• Track production costs against pricing targets and flag gaps early
• Confirm costing assumptions hold once the product is running at scale
• Issue the final launch report to close out each project
• Drive faster, cleaner changeovers between products and lines
• Train operators on new processes and equipment

Skills

Process engineering

Cross-functional collaboration

Education

Bachelor's degree in Packaging, Mechanical, Industrial, Manufacturing or Chemical Engineering

Job description

Capsum KKT is seeking a Project Engineer for a full-time role at our U.S. site to own process performance, lead investigations when batches go out of spec, drive validation, and ensure robust scale-up for new formulas.

You will collaborate with Quality, Compounding, Production, Maintenance, and R&D teams to optimize processes and support day-to-day manufacturing. The ideal candidate brings 5+ years in process engineering, hands-on experience with filling and packaging lines, and strong