MS&T Engineer, Drug Product – Sterile Fill-Finish

Afton Scientific, LLC; Charlottesville (VA); On-site; USD 95,000 - 145,000; Full time

Job summary

Afton Scientific, a Virginia-based contract manufacturing organization, is seeking a technically skilled MS&T Engineer - Drug Product to join the Manufacturing Science & Technology team. The role provides technical support for sterile fill-finish operations, drives process improvements, and collaborates across Manufacturing, Quality, and Engineering to ensure compliant, reliable production.

Responsibilities include technology transfer, validation support, deviation investigations, and preparing

Qualifications

• Bachelor's degree in chemical engineering, mechanical engineering, biomedical engineering, pharmaceutical sciences, life sciences, or related technical discipline.
• Three+ years in engineering, technical operations, process development, validation, or manufacturing in pharma/biotech.
• Working knowledge of cGMP requirements and pharmaceutical quality systems.
• Knowledge of process validation, equipment qualification, change control, deviations, investigations, and CAPA systems.
• Ability to investigate complex technical problems and develop practical, scientifically sound solutions.
• Strong analytical, organizational, project-management, and prioritization skills.
• Strong written and verbal communication skills and ability to work across functions.
• Ability to work on-site in controlled manufacturing areas with gowning and PPE requirements.

Responsibilities

• Provide daily technical support for sterile manufacturing and fill-finish operations.
• Monitor and analyze process data to identify variability, risks, trends, and improvement opportunities.
• Troubleshoot manufacturing, process, and equipment issues with cross-functional teams.
• Lead or support deviation investigations, root-cause analyses, CAPA, and effectiveness checks.
• Support product and process technology transfers, scale-up activities, protocols, and reports.
• Support process validation, equipment qualification, aseptic simulations, cleaning validation, and CPV.
• Prepare and maintain SOPs, batch records, technical reports, risk assessments, protocols, and controlled documents.
• Evaluate proposed process, equipment, material, and documentation changes through change-control.
• Design and analyze engineering studies using statistical and quality risk-management tools.
• Provide technical input for equipment decisions, client and regulatory communications, and audits.
• Train manufacturing personnel and ensure safety, data integrity, quality-system, and cGMP compliance.

Skills

Problem solving

Analytical thinking

Cross-functional collaboration

Project management

Attention to detail

Initiative and accountability

Effective communication

Education

Bachelor's degree in chemical engineering, mechanical engineering, biomedical engineering, pharmaceutical sciences, life sciences, or related technical discipline

Job description

Afton Scientific, a Virginia-based contract manufacturing organization, is seeking a technically skilled MS&T Engineer - Drug Product to join the Manufacturing Science & Technology team. The role provides technical support for sterile fill-finish operations, drives process improvements, and collaborates across Manufacturing, Quality, and Engineering to ensure compliant, reliable production.

Responsibilities include technology transfer, validation support, deviation investigations, and preparing