Senior Process Engineer
$110,000–$130,000 year
On-site · Colorado Springs, Colorado, United States
Job Summary
Senior Process Engineer responsible for designing, optimizing, and scaling manufacturing processes for nutraceutical products (solid dose, gummies, softgels) in a cGMP environment; leads process development and validation from pilot to commercial scale, drives continuous improvement, and partners with Product Development, Quality, and Operations. Requires deep expertise in solid-dose/gummy/softgel manufacturing, 21 CFR Part 111/117, process improvement/validation/controls, and Lean Six Sigma; duties include establishing CPPs/CQAs, data-driven yield and OEE improvements, CAPA closure, and cross-functional technical support across manufacturing, QA, and supply chain.
Required Qualifications
- Bachelor's degree in Chemical Engineering, Industrial Engineering, Food Engineering, Food Science, Pharmaceutical Sciences, or closely related field
- Lean Manufacturing certification or Six Sigma Green Belt or equivalent
- Minimum 6 years of progressive process engineering experience in nutraceutical, dietary supplement, or pharmaceutical GMP manufacturing
- Experience with solid-dose manufacturing equipment: blenders, granulators, mills, tablet presses, encapsulators, coating pans
- Hands-on experience with softgel and gummy manufacturing equipment: jacketed kettles, homogenizers, peristaltic pumps, softgel encapsulators, gummy depositors, drying rooms
- Experience in a CDMO environment
- Strong analytical and statistical skills; experience with SPC, Minitab, or equivalent tools
- Excellent technical writing skills; ability to author SOPs, protocols, technical reports, and deviation investigations
- Demonstrated ability to lead cross-functional projects and influence stakeholders without direct authority
- Exposure to ERP/MES systems, controlled document systems
- Experience with process validation (IQ/OQ/PQ) and cleaning validation protocols
- Knowledge of 21 CFR Part 111 cGMP requirements
- Project leadership and cross-functional collaboration
- Validation & Compliance
- Cross-Functional Collaboration
- Continuous Improvement & Leadership
- Mentor employees and cross-train production teams
- Quality Assurance
- Operations
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