6549 - Lead Process Engineer

United States·High Pointlead

EngineeringProcess Engineer

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Quick Summary

Key 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,

Requirements Summary

Bachelor's degree in Chemical Engineering, Pharmaceutical Sciences, Chemistry, Mechanical Engineering, or a related scientific/engineering discipline; advanced degree preferred.

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EngineeringProcess Engineer

Description

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

Responsibilities

~1 min read

→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

~2 min read

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—$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