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

Afton Scientific. LLC; Charlottesville (VA); Sur place; USD 95 000 - 145 000; Plein temps

Résumé du poste

Afton Scientific. LLC is seeking an MS&T Engineer - Drug Product to support sterile fill-finish manufacturing, resolve technical issues, and enable technology transfer and investigations. You will work across Manufacturing, Quality, and Engineering to keep processes reliable and compliant with cGMP.

The role emphasizes process validation, equipment qualification, and deviation investigations, with opportunities to contribute to regulatory-ready documentation and scale-up efforts.

Qualifications

• Bachelor's degree in chemical engineering, mechanical engineering, biomedical engineering, pharmaceutical sciences, life sciences, or a related technical discipline.
• Three+ years in engineering, technical operations, process development, validation, or manufacturing within pharma/biotech or a regulated industry.
• 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 across functions.
• Ability to work on-site and enter controlled manufacturing areas with gowning PPE requirements.

Responsabilités

• 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 technology transfers, scale-up activities, protocols, and reports.
• Support process validation, equipment qualification, aseptic simulations, cleaning validation, and CPPs.
• Prepare and maintain SOPs, batch records, technical reports, risk assessments, and controlled documents.
• Evaluate proposed changes through the change-control process.
• Design and analyze engineering studies to improve quality, yield, reliability, and efficiency.
• Provide technical input for equipment decisions, audits, and regulatory communications.
• Train operations personnel and ensure safety and data integrity compliance.

Connaissances

Sterile manufacturing

cGMP knowledge

Root-cause analysis

Data analysis

Cross-functional collaboration

Process validation

Equipment qualification

Documentation & SOPs

Problem solving

Formation

Bachelor's degree in chemical/biomedical/pharma sciences

Outils

Statistical tools

Quality systems

Description du poste

Afton Scientific. LLC is seeking an MS&T Engineer - Drug Product to support sterile fill-finish manufacturing, resolve technical issues, and enable technology transfer and investigations. You will work across Manufacturing, Quality, and Engineering to keep processes reliable and compliant with cGMP.

The role emphasizes process validation, equipment qualification, and deviation investigations, with opportunities to contribute to regulatory-ready documentation and scale-up efforts.