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

Afton Scientific; Charlottesville (VA); Vor Ort; USD 95.000 - 145.000; Vollzeit

Zusammenfassung

Afton Scientific in Virginia is seeking a technically skilled MS&T Engineer - Drug Product to support sterile fill-finish manufacturing, resolve technical issues, and assist technology transfer, validation, and investigations.

You will collaborate across Manufacturing, Quality, Engineering, Maintenance and other teams to maintain process reliability, compliance with cGMP, and data-driven process improvements.

Qualifikationen

• Bachelor's degree in chemical engineering, mechanical engineering, biomedical engineering, pharmaceutical sciences, life sciences, or a related technical discipline.
• Three or more years of experience in engineering, technical operations, process development, validation, or manufacturing within the pharmaceutical, biotechnology, or a similarly 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 skills and the ability to work effectively across functions.
• Ability to work on-site and enter controlled manufacturing areas while meeting applicable gowning and personal protective equipment requirements.

Aufgaben

• Provide daily technical support for sterile manufacturing and fill-finish operations, including compounding, filtration, filling, and inspection.
• Monitor and analyze process data to identify variability, risks, trends, and improvement opportunities.
• Troubleshoot manufacturing, process, and equipment issues in partnership with Manufacturing, Quality, Engineering, Maintenance, and other teams.
• Lead or support deviation investigations, root-cause analyses, corrective and preventive actions, and effectiveness checks.
• Support product and process technology transfers, scale-up activities, and related plans, studies, protocols, and reports.
• Support process validation, equipment qualification, aseptic process simulations, cleaning validation, and continued process verification.
• Prepare and maintain SOPs, batch records, technical reports, risk assessments, protocols, and other controlled documents.
• Evaluate proposed process, equipment, material, and documentation changes through the established change-control process.
• Design and analyze engineering studies using statistical and quality risk-management tools to improve quality, yield, reliability, and efficiency.
• Provide technical input for equipment decisions, client and regulatory communications, and internal, client, or regulatory audits.
• Train manufacturing personnel, coordinate technical deliverables, and comply with applicable safety, data-integrity, quality-system, and cGMP requirements.

Kenntnisse

Technical problem solving

Process analysis & improvement

Quality & regulatory compliance

Communication & collaboration

Attention to detail

Initiative & accountability

Sound judgement & decision making

Ausbildung

Bachelor's degree in engineering or related field

Tools

CAPA systems

Electronic quality systems

Jobbeschreibung

Afton Scientific in Virginia is seeking a technically skilled MS&T Engineer - Drug Product to support sterile fill-finish manufacturing, resolve technical issues, and assist technology transfer, validation, and investigations.

You will collaborate across Manufacturing, Quality, Engineering, Maintenance and other teams to maintain process reliability, compliance with cGMP, and data-driven process improvements.