6549 - Lead Process Engineer

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

Benefits offered by this job

Competitive pay

Health insurance

401(k) match

Paid time off

Tuition reimbursement

Job summary

Verista is seeking a Lead Process Engineer to serve as the SME for API micronization and particle-size reduction. You will lead or support R&D-to-GMP transfer, develop scalable milling processes, and collaborate across R&D, Manufacturing, Quality, and Validation teams.

The role requires hands-on milling expertise, PSD analysis, and the ability to drive process improvements for scalable manufacturing readiness and commercialization. A strong engineering background is essential.

Qualifications

• Bachelor's degree required with 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.

Responsibilities

• Serve as a technical SME for API micronization and particle-size reduction.
• Develop, optimize, and troubleshoot milling processes using 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.

Skills

Process development

Particle-size reduction

Troubleshooting

Cross-functional collaboration

Education

Bachelor's degree in Chemical Engineering

Advanced degree preferred

Tools

Jet milling

Fitz milling

Cryogenic milling

PSD characterization tools

Job description

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.

For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.*Verista is an equal opportunity employer.

National (US) Range: $95,865 USD - $181,634 USD

Benefits

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.
• Medical, Dental & Vision insurances
• FSA, DCARE, Commuter Benefits
• Supplemental Life, Hospital, Critical Illness and Legal Insurance
• Health Savings Account
• 401(k) Retirement Plan (Employer Matching benefit)
• 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

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