Engineer - Aseptic Filling

Location: Middletown, Delaware, United States; on-site

Company

Pharmaceutical and biotechnology manufacturing organization developing and supporting sterile drug product operations.

What you will do

• Serve as the primary equipment subject matter expert for vial and syringe filling systems, isolators, and lyophilization equipment.
• Provide engineering support across design review, vendor coordination, FAT/SAT, installation, commissioning, qualification, start-up, and routine operation.
• Lead technical troubleshooting, root cause analysis, corrective actions, equipment reliability improvements, and preventive maintenance enhancements.
• Support technology transfer, manufacturing scale-up, new product introduction, and equipment readiness activities.
• Partner with Manufacturing, Technical Services, Validation, Quality, Maintenance, and external equipment vendors.
• Support contamination control, aseptic process simulation, audits, inspections, deviations, CAPA, change controls, and equipment upgrades.

Requirements

• Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related technical discipline.
• At least 5 years of experience in the pharmaceutical or biotechnology industry.
• Hands-on experience with sterile filling equipment, including vial and/or syringe filling systems and isolator technology.
• Strong understanding of cGMP, risk-based approaches, FDA and EMA expectations, EU GMP Annex 1, ICH guidance, and relevant industry standards.
• Experience with lyophilization equipment, sterile manufacturing facility start-up or expansion, and equipment integration is preferred.
• Strong written and verbal communication skills with attention to detail.

Culture & Benefits

• Individual contributor position with no direct reports.
• Work with a global engineering organization on drug product engineering projects.
• Collaborate across Manufacturing, Quality, Validation, Technical Services, Maintenance, and external vendors.
• Support a compliant and controlled sterile manufacturing environment.