MS&T Engineer - Drug Product

•     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.

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

•     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.

•     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

•     Project Management

•     Communication and Collaboration

•     Attention to Detail

•     Sound Judgment and Decision Making

•     Initiative and Accountability

•     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.