Process Engineer, Tech Ops

About the role

The Process Engineer, Technical Ops is responsible for optimizing and troubleshooting manufacturing processes for tablet, capsule, and powder dietary supplement products. This role owns the technical performance of dry-fill, compression, encapsulation, blending, granulation, and powder-fill processes—driving process robustness, yield improvement, and consistent product quality from pilot scale through full commercial production.

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 critical process parameters (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 downtime.
• 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-conference 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.

Requirements

• 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.
• Strong cross-functional collaboration and communication skills, with ability to work directly with production floor personnel.
• Ability to work primarily on the manufacturing production floor, with regular exposure to operating equipment.
• Occasional lifting of up to 25 lbs. (materials, tooling, test equipment).
• Able to walk/stand for extended periods during production support and troubleshooting.
• Use of PPE (safety glasses, hearing protection, etc.) as required in the manufacturing environment.

Qualifications

• No specific qualifications listed beyond those already detailed in the Responsibilities section.

Skills

• Process engineering expertise in solid dose manufacturing (tablets, capsules, and powders).
• Strong troubleshooting and problem-solving skills.
• Knowledge of FDA regulations and cGMP requirements.
• Experience with process validation and equipment qualification.
• Ability to analyze process data and implement continuous improvement strategies.
• Effective communication and collaboration skills.

Benefits

No specific benefits listed beyond those mentioned in the job description.

Pay

No specific pay range provided beyond the estimate of $135,000 to $140,000.

Schedule

No specific schedule provided beyond the general statement of working primarily on the manufacturing production floor.