6549 - Lead Process Engineer

Verista, Inc.; High Point (NC); On-site; USD 96,000 - 182,000; Full time

Benefits offered by this job

Company-paid Insurance

Health Savings Account

PTO & Holidays

Tuition Reimbursement

Parental Leave

Job summary

Verista, Inc. is seeking a Lead Process Engineer to advance API micronization programs from R&D through GMP manufacturing.

You will lead development, scale-up, tech transfer, and CPP/CQAs, applying jet, Fitz, and cryogenic milling methods to optimize PSD and particle size targets. You will collaborate with R&D, Process Development, Manufacturing, Quality, Analytical, Validation, and other teams; write protocols, risk assessments, and tech transfer docs; ensure regulatory readiness and robust,

Qualifications

• Significant hands-on API process development and/or manufacturing experience.
• Demonstrated expertise in micronization and particle-size reduction.
• Hands-on experience with jet milling, Fitz milling, and cryogenic milling.
• Strong PSD characterization and interpretation experience.
• Experience scaling processes from R&D through GMP manufacturing.
• Understanding milling parameter effects on particle size and product performance.
• Experience supporting technology transfer, PPQ, and commercialization readiness.

Responsibilities

• Serve as a technical SME for API micronization and particle-size reduction processes.
• Develop, optimize, and troubleshoot milling processes using jet mills, Fitz Mills, and cryogenic milling systems.
• Lead or support process development, scale-up, and tech transfer for R&D-stage API programs.
• Evaluate PSD and establish particle-size targets, ranges, and control strategies.
• Identify CPPs and CQAs associated with micronization.
• Design studies to improve process understanding, robustness, and scalability.
• Support development for future GMP manufacturing, PPQ, and commercialization.
• Collaborate cross-functionally with R&D, Process Development, Manufacturing, Quality, Analytical, Validation, and other teams.
• Prepare and review technical documentation, reports, protocols, risk assessments, and tech-transfer documents.
• Troubleshoot milling and particle-size issues and provide recommendations.

Skills

Micronization

PSD analysis

Process development

Jet milling

Fitz milling

Cryogenic milling

GMP manufacturing

Cross-functional communication

Education

Bachelor's degree in Chemical Engineering

Advanced degree preferred

Tools

Jet milling

Fitz milling

Cryogenic milling

Job description

Verista's 500 experts team up with the world's most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world's most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision‑making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world‑class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

Lead Process Engineer Responsibilities:

• Serve as a technical SME for API micronization and particle‑size reduction processes.
• Develop, optimize, and troubleshoot micronization and milling processes using equipment such as jet mills, Fitz Mills, and cryogenic milling systems.
• Lead or support process development, characterization, scale‑up, and technology transfer activities for R&D‑stage API programs.
• Evaluate and characterize Particle Size Distribution (PSD) and establish appropriate particle‑size targets, ranges, and control strategies.
• Assess the relationship between milling parameters, particle characteristics, material properties, and overall product/process performance.
• Identify and define Critical Process Parameters (CPPs) and relevant Critical Quality Attributes (CQAs) associated with micronization.
• Design and execute studies to improve process understanding, robustness, reproducibility, and scalability.
• Support development of processes suitable for future GMP manufacturing, process validation, PPQ, and commercialization.
• Partner cross‑functionally with R&D, Process Development, Manufacturing, Quality, Analytical, Validation, and other technical teams.
• Author and review technical documentation, development reports, protocols, risk assessments, and technology‑transfer documentation.
• Troubleshoot milling and particle‑size issues and provide technically sound recommendations for process improvement.
• Ensure development activities appropriately consider future regulatory, GMP, validation, and commercial manufacturing requirements.

Requirements:

• Bachelor's degree in Chemical Engineering, Pharmaceutical Sciences, Chemistry, Mechanical Engineering, or a related scientific/engineering discipline; advanced degree preferred.
• Significant hands‑on experience with pharmaceutical API process development and/or manufacturing.
• Demonstrated expertise in micronization and particle‑size reduction.
• Hands‑on experience with jet milling, Fitz milling, cryogenic milling, or comparable pharmaceutical milling technologies.
• Strong experience with Particle Size Distribution (PSD) characterization, analysis, and interpretation.
• Experience developing and scaling processes from R&D/development through GMP manufacturing.
• Understanding of how milling parameters affect particle size, material characteristics, product performance, process robustness, and manufacturability.
• Experience supporting technology transfer, process validation, PPQ, and/or commercialization readiness.
• Strong knowledge of GMP pharmaceutical manufacturing requirements.
• Ability to lead technical investigations, analyze process data, troubleshoot complex process issues, and communicate recommendations to cross‑functional stakeholders.

National (US) Range

$95,865 - $181,634 USD

Why Choose Verista?

• High growth potential and fast‑paced organization with a people‑focused culture
• Competitive pay plus performance‑based incentive programs
• Company‑paid Life, Short‑Term, and Long‑Term Disability Insurance.
• Supplemental Life, Hospital, Critical Illness and Legal Insurance
• Health Savings Account
• Paid Time Off (Rollover Option) and Holidays
• As Needed Sick Time
• Tuition Reimbursement
• Team Social Activities (We have fun!)
• Employee Recognition
• Employee Referral Program
• Paid Parental Leave and Bereavement

Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details.

For more information about our company, please visit us at Verista.com