MS&T Engineer - Drug Product

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

Job summary

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.

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 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.

Skills

Sterile manufacturing

cGMP knowledge

Root-cause analysis

Data analysis

Cross-functional collaboration

Process validation

Equipment qualification

Documentation & SOPs

Problem solving

Education

Bachelor's degree in chemical/biomedical/pharma sciences

Tools

Statistical tools

Quality systems

Job description

Afton Scientific is a contract manufacturing organization (CMO) in Virginia that specializes in small-batch filling of injectables from clinical trials to approved commercial drugs.

Utilizing 35,000 Sq. Ft of manufacturing, lab, warehouse, and administrative space, Afton provides custom, innovative solutions for clinical to commercial sterile manufacturing, packaging and labeling, analytical and micro lab services, and pharmaceutical support services.

Our Ready-To-Fill® line continues with our philosophy of guidance and support for our clients. It offers top-quality pre-sterilized components to those who can fill in-house.

• Serving clients in 18 Countries
• Successful NDA and ANDA drug registrations
• In good standing with the FDA, PMDA, and MHRA

NOTE: Afton Scientific does not sponsor work visas. No recruiters please.

Afton Scientific is seeking a technically skilled, collaborative, and solutions-oriented MS&T Engineer - Drug Product to join our Manufacturing Science & Technology team. This position supports sterile fill-finish manufacturing by resolving technical issues, improving processes, and supporting technology transfer, validation, and investigations.

This is an excellent opportunity for an employee who enjoys applying scientific and engineering principles, solving complex manufacturing problems, and partnering across departments to keep operations reliable, controlled, and compliant with cGMP requirements.

Compensation

$95,000 to $145,000 annually

Placement within the range will be based on qualifications, relevant experience, internal equity, and demonstrated competencies.

Primary Responsibilities

• 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.

Minimum Qualifications

• 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.

Preferred Knowledge and Experience

• Experience supporting sterile manufacturing, aseptic processing, or pharmaceutical fill-finish operations.
• Experience working in a contract development and manufacturing organization environment.
• Understanding of contamination-control principles and good documentation practices.
• Experience with root-cause analysis and risk-management tools such as 5 Whys, fishbone analysis, fault-tree analysis, and FMEA.
• Experience preparing technical protocols, reports, procedures, risk assessments, and presentations.
• Experience using electronic quality, manufacturing, or document-management systems.
• Technical Problem Solving
• Process Analysis and Improvement
• Quality and Regulatory Compliance
• Communication and Collaboration
• Attention to Detail
• Sound Judgment and Decision Making
• Initiative and Accountability

What You'll Gain

• Hands-on experience supporting sterile fill-finish manufacturing and aseptic processing.
• Increased exposure to technology transfer, validation, investigations, and process improvement.
• Opportunities to collaborate with Manufacturing, Quality, Engineering, Maintenance, and other functional teams.
• Experience contributing directly to product quality, process reliability, yield, and operational efficiency.
• An opportunity to expand technical leadership skills and pursue continued career growth within Afton Scientific.