Verista

GxP lifecycle consulting for life sciences

Lead Process Engineer

Bioprocess & BiomanufacturingConfirmed live in the last 24 hours

Full-timeHigh Point, NC, USAIn-person

About the Job

Requirements

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

Responsibilities

Serve as a technical subject matter expert 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 research and development-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 and 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 research and development, 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.

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—$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

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

National (US) Range 95865 - 181634 USD

About the Company

Verista

GxP lifecycle consulting for life sciences

Verista provides business and technology consulting for life science companies, focusing on systems, compliance, validation and quality across the GxP lifecycle. Its services cover preclinical, clinical, commercialization, manufacturing and distribution to ensure safe, high-quality results. The company combines decades of industry knowledge with advanced engagement platforms and transformative technologies to help clients solve complex challenges with one partner across specialties. With a team of 500+ experts, Verista supports clients from strategy and validation to execution, delivering consistent, compliant outcomes that improve health and lives. The goal is to enable better health outcomes by ensuring products and processes are safe, compliant and efficient throughout the product development lifecycle.

Company size: 201-500
Company stage: Not listed
Total funding: Not listed
Headquarters: Fishers, IN
Founded: 2020

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