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

BioSpace; Charlottesville (VA); Sur place; USD 95 000 - 145 000; Plein temps

Résumé du poste

Afton Scientific in Virginia seeks an MS&T Engineer - Drug Product to join our Manufacturing Science & Technology team. The role supports sterile fill-finish manufacturing by resolving technical issues, improving processes, and supporting technology transfer, validation, and investigations.

This position applies scientific and engineering principles to solve complex manufacturing problems and partners across departments to maintain reliable, controlled, and compliant operations under cGMP

Qualifications

• Bachelor's degree in a technical discipline (chem eng, mech eng, bio eng, pharma sci, life sciences).
• 3+ years in engineering, technical ops, process development, validation, or manufacturing in a regulated/pharma setting.
• Working knowledge of cGMP requirements and pharmaceutical quality systems.
• Knowledge of process validation, equipment qualification, change control, deviations, investigations, and CAPA systems.

Responsabilités

• Provide daily technical support for sterile manufacturing and fill-finish operations.
• Monitor and analyze process data to identify variability, risks, trends, and opportunities.
• Troubleshoot manufacturing, process, and equipment issues with cross-functional teams.
• Lead or support deviation investigations and corrective/preventive actions.
• Support technology transfers, scale-up activities, and related plans/reports.
• Support process validation, equipment qualification, aseptic simulations, cleaning validation, and PPQ.
• Prepare and maintain SOPs, batch records, and controlled documents.
• Evaluate proposed process/equipment/document changes via change-control.
• Design engineering studies using statistics and quality risk tools to improve quality and yield.
• Provide technical input for equipment decisions, client and regulatory communications, audits.
• Train personnel and ensure compliance with safety, data integrity, quality systems, and cGMP.

Connaissances

Technical problem solving

Process analysis

Quality/regulatory compliance

Project management

Communication and collaboration

Attention to detail

Decision making

Initiative

Formation

Bachelor's degree in chemical engineering

Bachelor's degree in mechanical engineering

Bachelor's degree in biomedical engineering

Bachelor's degree in pharmaceutical sciences

Bachelor's degree in life sciences

Description du poste

Afton Scientific in Virginia seeks an MS&T Engineer - Drug Product to join our Manufacturing Science & Technology team. The role supports sterile fill-finish manufacturing by resolving technical issues, improving processes, and supporting technology transfer, validation, and investigations.

This position applies scientific and engineering principles to solve complex manufacturing problems and partners across departments to maintain reliable, controlled, and compliant operations under cGMP