6577 - Senior Process Engineer

About the role

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.

We are seeking an experienced Process Engineer – Manufacturing Science and Technology (MSAT) to support GMP biologics drug substance manufacturing. This role will focus on technology transfer, process scale‑up, manufacturing support, and technical troubleshooting within a CDMO environment.

Responsibilities

• Serve as a technical Subject Matter Expert (SME) supporting GMP biologics drug substance manufacturing.
• Lead technology transfer activities from process development and external clients into manufacturing.
• Support process development, scale‑up, optimization, and manufacturing process design.
• Develop, review, and maintain Master Batch Records (MBRs) and manufacturing documentation.
• Provide technical expertise for upstream and/or downstream biologics manufacturing operations.
• Support deviation investigations, impact assessments, CAPAs, change controls, and other QMS activities.
• Evaluate process parameters, CQAs, CPPs, and Quality Target Product Profiles (QTPPs).
• Troubleshoot manufacturing issues and implement process improvements.
• Collaborate with Manufacturing, Quality, Engineering, and external clients to ensure successful process execution.
• Support process characterization, validation, and manufacturing readiness activities.

Requirements

• Bachelor's degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related discipline.
• Experience in MSAT, process engineering, or process development within biologics manufacturing.
• Strong technology transfer experience supporting GMP biologics drug substance manufacturing.
• Hands‑on knowledge of upstream and/or downstream manufacturing processes.
• Experience with process scale‑up, process design, and manufacturing optimization.
• Experience developing or reviewing Master Batch Records and GMP documentation.
• Knowledge of QTPPs, CQAs, CPPs, and biologics process development.
• Experience with GMP quality systems, including deviations, CAPAs, change controls, and impact assessments.
• Excellent communication, interpersonal, and client‑facing skills.
• Ability to work independently and provide technical expertise with minimal training.

Qualifications

• Previous MSAT experience within a CDMO environment.
• Experience with both upstream and downstream biologics operations.
• Experience with bioreactors, cell culture, chromatography, filtration, or UF/DF.
• Experience supporting process characterization, PPQ, and process validation.
• Direct experience managing client‑facing technology transfer activities.

Benefits

• 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