Process Documentation Jobs in Colorado (NOW HIRING)

Position Summary:

The Senior Process Engineer is responsible for designing, optimizing, and scaling manufacturing processes that produce high‐quality nutraceutical products efficiently, safely, and in compliance with cGMP. This role leads process development and validation from pilot through commercial scale, drives continuous improvement, and partners cross‐functionally with Product Development, Quality, and Operations. The ideal candidate brings deep process engineering expertise in solid dose/gummy/softgel manufacturing, with a strong command of cGMP (21 CFR Part 111/117), process improvement/validation/controls, and Lean Six Sigma methodologies.

Essential Functions and Basic Duties:

Process Development & Optimization

• Lead process development activities for new and existing supplement products across dosage forms including capsules, tablets, powders, softgels, and gummies.
• Design and execute process scale-up from pilot/bench scale to full commercial manufacturing with documented justification and data analysis.
• Design and execute waste stream and value stream mapping studies, process characterization, and performance vs capability analyses to enhance efficiency of manufacturing, bolster first-pass quality metric (internally denoted as ‘First Time Right’ metric), and increased cost savings for the organization.
• Establish and maintain Critical Process Parameters (CPPs), Critical Quality Attributes (CQAs), and control strategies for all manufacturing processes.
• Continuously analyze production data to identify improvement opportunities and drive measurable gains in yield, reduction in machine down-time, and overall equipment effectiveness (OEE).
• Drive post-launch process optimization for commercialized products, using production performance data, consumer feedback, and quality trends to identify and implement targeted improvements that reduce variability, improve consistency, and lower cost of goods.

Validation & Compliance

• Author and execute process validation protocols (IQ/OQ/PQ) in full compliance with 21 CFR Part 111 cGMP requirements.
• Maintain process documentation including SOPs, manufacturing batch records (MBRs), and change control records in collaboration with internal Documentation Specialist(s), Product Development, and Quality Assurance.
• Support internal quality audits, inspections, and UL/NSF or third-party certification reviews as requested.
• Lead investigation and root cause analysis for manufacturing deviations and out-of-specification (OOS) results, authoring CAPAs to allow for effective closure with assistance of Quality Assurance.

Cross-Functional Collaboration

• Provision of day-to-day technical assistance to Operations for product manufacturing run challenges and training of Operators where applicable.
• Partner with Product Development and Operations to qualify new product formulations, ensuring seamless transfer to manufacturing.
• Work with Product Development, Quality Control, and Quality Assurance to evaluate raw material specifications and supplier qualifications.
• Serve as a technical resource for Sales and Marketing during customer inquiries and product capability discussions as requested.

Continuous Improvement & Leadership

• Champion a culture of continuous improvement using Lean, Six Sigma, and Kaizen methodologies across the manufacturing floor.
• Conduct structured post-launch reviews for all new products at 30-, 90-, and 180-day intervals, benchmarking actual process performance against validation targets and initiating improvement projects where gaps are identified.
• Maintain a living continuous improvement roadmap for all manufacturing lines, prioritizing initiatives by impact on quality, efficiency, and cost.
• Lead or participate in capital improvement projects, including equipment procurement, FAT/SAT, installation, and qualification.
• Mentor employees (as needed) and cross-train production team members on process best practices and GMP expectations.
• Track and report on product development KPIs including first-pass yield, scrap rates, machine usage and deviation frequency in collaboration with Operations.

Education / Certifications:

• Bachelor's degree in Chemical Engineering, Industrial Engineering, Food Engineering, Food Science, Pharmaceutical Sciences, or a closely related field.
• Lean Manufacturing certification or Six Sigma Green Belt or equivalent.

Required Knowledge:

• Functional knowledge of current industrial practices related to wet and dry granulation, 2-piece encapsulation, tablet compression, softgel encapsulation, and gummy manufacturing.
• Deep, demonstrable knowledge of 21 CFR Part 111 cGMP requirements.
• Proven track record executing process validation (IQ/OQ/PQ) and cleaning validation protocols.
• Strong analytical and statistical skills; experience with SPC, Minitab, or equivalent tools.
• Excellent technical writing skills; ability to author clear 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.

Required Experience:

• Minimum 6 years of progressive process engineering experience in nutraceutical, dietary supplement, or pharmaceutical GMP manufacturing
• Strong experience with Six Sigma and Lean
• Comfortable leading / implementing new processes and educating cross-functional cohorts (Ops/Quality/Management) on their importance.
• Experience with powder, gummy, softgel, tablets and capsules supplement manufacturing both from a controls and machine operation standpoint.
• Experience in a Contract Development & Manufacturing Organization (CDMO) environment.
• Hands-on experience with solid-dose manufacturing equipment: blenders, granulators, mills, tablet presses, encapsulators, and coating pans.
• Hands-on experience with softgel and gummy manufacturing equipment: jacketed kettles, homogenizers, peristaltic pumps, softgel encapsulators, gummy depositors, and drying rooms / batch dryers.

Preferred Education and Experience:

• Masters Degree in Chemical Engineering, Industrial Engineering, Food Engineering, Food Science, Pharmaceutical Sciences, or a closely related field.
• Lean Six Sigma Black Belt.
• PMP and/or PE license desired

As we prepare to embark on our centennial journey, New Generation Wellness (NGW) is not just marking a milestone; we are celebrating a century of commitment to health, vitality, and positive transformation. For 100 years, we've been at the forefront of wellness, pioneering innovation, and shaping the future of holistic health. We invite you to be part of our legacy. Joining New Generation Wellness means becoming a part of a dynamic and successful team that values innovation, collaboration, and exceeding the needs of our customers. Here's to the next 100 years of New Generation Wellness! More importantly, here’s to your success!