MS&T Engineer - Drug Product

Location: On-site in Charlottesville, Virginia, United States

Salary: $95,000–$145,000 annually

Company

hirify.global is a Virginia-based contract manufacturing organization providing sterile pharmaceutical manufacturing, packaging, labeling, laboratory, analytical, and pharmaceutical support services from clinical trials through commercial production.

What you will do

• Provide daily technical support for sterile manufacturing and fill-finish operations, including compounding, filtration, filling, and inspection.
• Analyze process data to identify variability, risks, trends, and improvement opportunities.
• Troubleshoot manufacturing, process, and equipment issues with Manufacturing, Quality, Engineering, Maintenance, and other functions.
• Lead or support deviation investigations, root-cause analyses, CAPA activities, and effectiveness checks.
• Support technology transfers, scale-up, process validation, equipment qualification, aseptic process simulations, cleaning validation, and continued process verification.
• Prepare controlled documents, evaluate changes, conduct engineering studies, support audits, and train manufacturing personnel.

Requirements

• Bachelor’s degree in chemical, mechanical, biomedical, or related engineering; pharmaceutical sciences; life sciences; or a related technical discipline.
• At least three years of experience in engineering, technical operations, process development, validation, or manufacturing within a pharmaceutical, biotechnology, or similarly regulated industry.
• Working knowledge of cGMP requirements, pharmaceutical quality systems, process validation, equipment qualification, change control, deviations, investigations, and CAPA.
• Ability to investigate complex technical problems and develop practical, scientifically sound solutions.
• Strong analytical, organizational, project-management, prioritization, written communication, and cross-functional collaboration skills.
• Ability to work on-site and enter controlled manufacturing areas while meeting gowning and personal protective equipment requirements.

Nice to have

• Experience with sterile manufacturing, aseptic processing, or pharmaceutical fill-finish operations.
• Experience in a contract development and manufacturing organization.
• Knowledge of contamination-control principles, good documentation practices, electronic quality systems, and document-management systems.
• Experience with 5 Whys, fishbone analysis, fault-tree analysis, FMEA, and technical protocols or reports.

Culture & Benefits

• Hands-on exposure to sterile fill-finish manufacturing and aseptic processing.
• Cross-functional collaboration with Manufacturing, Quality, Engineering, Maintenance, and other teams.
• Direct contribution to product quality, process reliability, yield, and operational efficiency.
• Opportunities to expand technical leadership skills and pursue continued career growth.
• Work visa sponsorship is not available.