Process Engineer

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.