Process Engineer, Tech Ops: Scale-Up & Optimization

MeriCal®; Orange (CA); On-site; USD 135,000 - 140,000; Full time

Benefits offered by this job

No-cost vision insurance

Life insurance

Generous paid time off

401(k) matching

Job summary

MeriCal in Southern California is seeking a Process Engineer, Technical Ops to optimize tablet, capsule, and powder manufacturing, driving CPPs, yield, and quality from pilot to full-scale production. You will partner with Manufacturing, Quality, R&D, and Maintenance to design efficient, compliant processes on the production floor.

The role emphasizes hands-on problem solving, continuous improvement with Lean/Six Sigma, and documentation of batch records and SOPs, while supporting equipment

Qualifications

• Bachelor's degree in Packaging Engineering, Engineering, Materials Science, Food Science, or a related scientific field.
• 3+ years of process engineering experience in solid dose manufacturing (tablets, capsules and/or powders) within dietary supplements, pharmaceuticals, or nutraceuticals.
• Hands-on experience with solid dose processing equipment: tablet presses, encapsulators, high-shear/fluid bed granulators, blenders (V-blender, bin blender), and powder-filling equipment.
• Working knowledge of FDA regulations for dietary supplements (21 CFR Part 111) and cGMP requirements.
• Strong troubleshooting skills demonstrated experience resolving in process manufacturing and equipment issues.
• Experience with process validation and equipment qualification (IQ/OQ/PQ).
• Familiarity with in-process testing methods (weight variation, hardness, friability, disintegration, moisture analysis).
• Ability to read and interpret process data, batch records, and technical specifications.

Responsibilities

• Own and optimize manufacturing processes for tablets (compression, coating), capsules (encapsulation), and powders (blending, granulation, fill/finish).
• Lead process development and scale-up activities from pilot batches through commercial-scale production runs, establishing and validating CPPs.
• Investigate and resolve in-process manufacturing issues, including blending inconsistencies, tablet weight/hardness/friability variation, capsule fill weight variation, granulation defects, powder flowability/segregation issues, and coating defects.
• Partner with Manufacturing and Maintenance to troubleshoot equipment-related process issues (tablet presses, encapsulators, blenders, granulators, fluid bed processors, powder fillers) and minimize downsize.
• Conduct root cause analysis for process deviations, out-of-specification results, and recurring production issues; implement corrective and preventive actions (CAPA).
• Identify and lead process optimization and cost-savings initiatives, including cycle time reduction, yield improvement, and waste reduction.
• Develop, review, and maintain process documentation, including batch manufacturing records, standard operating procedures (SOPs), process flow diagrams, and equipment setup/changeover instructions.
• Support equipment qualification (IQ/QQ/PQ) and process validation activities for new and existing equipment/processes.
• Evaluate and recommend equipment upgrades, tooling changes, or process technology improvements to support capacity, quality, or efficiency goals.
• Collaborate with Formulation Scientist during technology transfer to ensure new formulations are process-compatible and scalable on existing equipment.
• Support change controls, deviations, and non-conformance report (NCR) investigations related to process or equipment issues.
• Provide hands-on technical support and training to production operators and technicians on process parameters and troubleshooting.
• Analyze process data (e.g., SPC/trending) to proactively identify variability and drive continuous improvement using Lean/Six Sigma methodologies.

Skills

Process engineering

Troubleshooting

Cross-functional collaboration

Reading process data

Lean Six Sigma

Education

Bachelor's degree in Packaging Engineering, Engineering, Materials Science, Food Science, or related field

Tools

Tablet presses

Encapsulators

High-shear granulators

Fluid bed granulators

Powder filling equipment

V-blender

Job description

MeriCal in Southern California is seeking a Process Engineer, Technical Ops to optimize tablet, capsule, and powder manufacturing, driving CPPs, yield, and quality from pilot to full-scale production. You will partner with Manufacturing, Quality, R&D, and Maintenance to design efficient, compliant processes on the production floor.

The role emphasizes hands-on problem solving, continuous improvement with Lean/Six Sigma, and documentation of batch records and SOPs, while supporting equipment