The Opportunity: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. The Process Engineer works closely with Manufacturing, Quality, R&D, and Maintenance to solve equipment and process-related issues and to design processes that are efficient, repeatable, and compliant.
What You'll Do:- 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 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-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.
What You'll Bring:- Bachelor's degree in Packaging Engineering, Engineering, Materials Science, Food Science, or a related scientific field.
- 3+ yeas of process engineering experience in solid dose manufacturing (tablets, capsules and/or powders) within dietary supplements, pharmaceuticals, or nutraceuticals.
- Hand's-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, hardiness, 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).
- Ability 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.
The Perks:- No-cost vision insurance (yes, you read that right!), employer-paid life insurance, paid company holidays, generous paid time off, sick leave, employee assistance program, and a comprehensive wellness program.
- Affordable medical and dental insurance plans tailored for you and your dependents.
- Exceptional supplemental benefits, including Accident, Critical Illness, Hospitalization indemnity plans, and pet insurance.
- 401(k) matching plan and more!
A reasonable estimate of the current base pay range for this position is $135,000. to $140,000.
The compensation offered may vary depending on the candidate's geographic region, job-related knowledge, skills, and/or education.