Hiring.fm
Byheart

Senior Principal Process Engineer

All Locations Full Time

ByHeart is an infant nutrition company built from the ground up to deliver real innovation on behalf of babies and parents. Our mission is simple: make the best formula in the world. That’s why we studied the latest breast milk science, worked directly with suppliers we know and trust, set uncompromising quality standards, developed our own small batch blending process, built our own manufacturing facilities, and conducted a groundbreaking clinical trial. Our goal is to create a future where all parents feel amazing about feeding their baby—no matter how they do it.

When we launched our Whole Nutrition Infant Formula in 2023, we were the first new US infant formula manufacturer in 15 years. Since then, we’ve been leading the way in a lot of ways. 

We’re…

  • The first and only US-made* infant formula made with organic, grass-fed whole milk, not skim.
  • The first and only U.S. infant formula company to add the two most abundant proteins found in breast milk—alpha-lac and lactoferrin—to our ingredients list.
  • The first infant formula company to receive Clean Label Project’s Purity Award (and we test for 700 contaminants vs the required 400).
  • We ran one of the largest clinical trials in the US in 25 years.
  • Our clinically proven benefits include:
    • Less spit up**
    • Softer poops**
    • Easier digestion
    • More efficient weight gain

*Made with globally sourced ingredients.

**Vs a leading infant formula

As the only new entrant to establish three US manufacturing facilities (in Pennsylvania, Iowa, and Oregon), ByHeart has the capacity to meaningfully capture share of the US $6B infant formula market. With >$470M in funding, we’re shifting the industry forward—and this is just the beginning. Help us build a future where all parents can feel amazing about feeding, by joining our growing team of >360 people that stretches across the country.

We're proud to offer competitive, family-first benefits, including but not limited to: 

  • Health insurance for the whole family: medical, dental, & vision insurance covered 100%, with 90% coverage for your family.
  • Flexible paid time off: plus 12+ company holidays, and your kid’s birthday off!
  • 16-weeks of fully-paid parental leave and new parent support: free 1-year supply of formula, cozy feeding suites, and paid pumping time.
  • Up to 6% 401(k) Match to help you plan for your future.
  • Company equity for every employee: because when we succeed, we succeed together!

Visit our site to learn more.

ByHeart In the News

 

ROLE DESCRIPTION

The Senior Principal Process Engineer is responsible for leading manufacturing process design, scale-up, and optimization. The role provides strategic technical direction, mentorship of process engineers, and leads cross-functional initiatives to enhance product quality, regulatory compliance, and operational efficiency.

Reports To:      VP, Supply Operations

Location:         Remote

Key Responsibilities

  1. Process Design & Optimization
  • Lead process design for new and existing product lines, including spray drying, blending, CIP, and packaging operations.
  • Develop and validate process parameters to ensure consistent quality and compliance with FDA and GMP standards.
  • Perform root cause analyses for process deviations and implement corrective and preventive actions (CAPA).
  1. Technical Leadership & Innovation
  • Serve as the SME (Subject Matter Expert) for critical process technologies (e.g., thermal processing, mixing, evaporation, drying).
  • Drive continuous improvement projects focused on yield improvement, energy reduction, and waste minimization.
  • Partner with R&D to scale new formulations from pilot to full production.
  1. Compliance & Validation
  • Author and approve process validation protocols and reports (IQ/OQ/PQ).
  • Ensure process documentation aligns with FDA, FSMA, and internal Quality Management System (QMS) standards.
  • Collaborate with Quality Assurance and Regulatory Affairs to prepare for inspections and audits.
  1. Cross-Functional Collaboration
  • Partner with Manufacturing, Maintenance, and Quality leaders to troubleshoot and improve line performance.
  • Support capital project execution by defining process requirements and equipment specifications.
  • Lead training and mentoring for Process Engineers and Production Supervisors.
  1. Data Analysis & Reporting
  • Use process modeling and data analytics (SPC, DOE, Six Sigma tools) to identify opportunities for process stability and optimization.
  • Present technical findings and recommendations to executive leadership and cross-functional teams.
  1. Travel
  • Up to 50% of travel to sites.

Qualifications

  • Education: Bachelor’s or Master’s in Chemical, Mechanical, or Process Engineering (PhD preferred).
  • Experience: 10–15+ years of process engineering experience in FDA-regulated manufacturing, ideally with infant formula, dairy, or food ingredients.
  • Certifications: Six Sigma Black Belt or Lean certification preferred.

Skills:

  • Advanced process modeling (Aspen, MATLAB, Minitab, etc.)
  • Strong understanding of cGMP, HACCP, and sanitary design principles
  • Exceptional technical writing and documentation skills
  • Proven leadership and mentoring abilities

Core Competencies

  • Decision Quality – Makes sound technical decisions that balance innovation with regulatory compliance.
  • Tech Savvy – Leverages process automation, sensors, and digital twin technologies to enhance efficiency.
  • Drives Results – Delivers measurable improvements in throughput, yield, and quality.
  • Collaborates – Works effectively across disciplines to solve complex operational challenges.
  • Ensures Accountability – Maintains high standards for process integrity and validation rigor.

We’re excited about your interest in joining ByHeart! Our Talent Acquisition team reviews applications in the order they are received and will reach out directly to schedule interviews. We kindly ask that you refrain from contacting hiring managers or current employees directly.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.