Process Engineer, Tech Ops — Scale-Up & Optimization

Merical Inc.; Ogden, Northern (UT, KY); Hybrid; USD 135,000 - 140,000; Full time

Benefits offered by this job

Vision insurance

Life insurance

Holidays

401(k) matching

Job summary

MeriCal is seeking a Process Engineer, Technical Ops to optimize and troubleshoot tablet, capsule, and powder manufacturing processes. You will own dry-fill, compression, encapsulation, blending, granulation, and powder-fill operations from pilot to full production, collaborating with Manufacturing, Quality, R&D, and Maintenance to ensure robust, compliant processes.

You will focus on process development, CPP validation, CAPA, and cost-saving initiatives, while maintaining comprehensive process

Qualifications

• Bachelor’s degree in Packaging Engineering, Engineering, Materials Science, Food Science, or related field.
• 3+ years of process engineering experience in solid dose manufacturing (tablets, capsules and/or powders).
• Hands-on experience with solid dose processing equipment: tablet presses, encapsulators, blenders, granulators, and powder-fill equipment.
• Working knowledge of FDA regulations for dietary supplements (21 CFR Part 111) and cGMP requirements.
• Strong troubleshooting skills in process manufacturing and equipment issues.
• Experience with process validation and equipment qualification (IQ/OQ/PQ).

Responsibilities

• Own and optimize manufacturing processes for tablets, capsules, and powders.
• Lead process development and scale-up from pilot to production.
• Investigate and resolve in-process issues including weight, hardness, friability, and flow.
• Troubleshoot equipment-related issues with multiple machines.
• Conduct root cause analysis for deviations and CAPA.
• Lead process optimization and cost-saving initiatives.
• Maintain process documentation (Batch records, SOPs, flow diagrams).
• Support equipment qualification and validation activities.
• Evaluate equipment upgrades or process improvements for capacity and quality.
• Collaborate with formulation scientists during technology transfer.
• Support change controls and NCR investigations.
• Provide hands-on training to production staff.
• Analyze process data to drive continuous improvement using Lean/Six Sigma.

Skills

Process engineering

Solid dose manufacturing

Troubleshooting

FDA regulations

cGMP

IQ/OQ/PQ

Data analysis

Cross-functional collab

Education

Bachelor’s degree in Packaging Eng or related

Tools

Tablet presses

Encapsulators

Blenders

Granulators

Powder fillers

High-shear granulators

Job description

MeriCal is seeking a Process Engineer, Technical Ops to optimize and troubleshoot tablet, capsule, and powder manufacturing processes. You will own dry-fill, compression, encapsulation, blending, granulation, and powder-fill operations from pilot to full production, collaborating with Manufacturing, Quality, R&D, and Maintenance to ensure robust, compliant processes.

You will focus on process development, CPP validation, CAPA, and cost-saving initiatives, while maintaining comprehensive process